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176.170 Components of paper and paperboard in contact with aqueous and fatty foods.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.170]

[Page 197-223]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 176_INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table 
of Contents
 
 Subpart B_Substances for Use Only as Components of Paper and Paperboard
 
Sec.  176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

    Substances identified in this section may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard intended for use in producing, manufacturing, packaging, 
processing, preparing, treating, packing, transporting, or holding 
aqueous and fatty foods, subject to the provisions of this section. 
Components of paper and paperboard in contact with dry food of the type 
identified under Type VIII of table 1 in paragraph (c) of this section 
are subject to the provisions of Sec.  176.180.
    (a) Substances identified in paragraph (a) (1) through (5) of this 
section may be used as components of the food-contact surface of paper 
and paperboard. Paper and paperboard products shall be exempted from 
compliance with the extractives limitations prescribed in paragraph (c) 
of this section: Provided, That the components of the food-contact 
surface consist entirely of one or more of the substances identified in 
this paragraph: And provided further, That if the paper or paperboard 
when extracted under the conditions prescribed in paragraph (c) of this 
section exceeds the limitations on extractives contained in paragraph 
(c) of this section, information shall be available from manufacturing 
records from which it is possible to determine that only substances 
identified in this paragraph (a) are present in the food-contact surface 
of such paper or paperboard.
    (1) Substances generally recognized as safe in food.
    (2) Substances generally recognized as safe for their intended use 
in paper and paperboard products used in food packaging.
    (3) Substances used in accordance with a prior sanction or approval.
    (4) Substances that by regulation in parts 170 through 189 of this 
chapter may be safely used without extractives limitations as components 
of the uncoated or coated food-contact surface of paper and paperboard 
in contact with aqueous or fatty food, subject to the provisions of such 
regulation.
    (5) Substances identified in this paragraph, as follows:

------------------------------------------------------------------------
           List of Substances                      Limitations
------------------------------------------------------------------------
Acetyl peroxide........................  For use only as polymerization
                                          catalyst.
Acrylamide-methacrylic acid-maleic       For use only as a retention aid
 anhydride copolymers containing not      employed prior to the sheet-
 more than 0.2 percent of residual        forming operation in the
 acrylamide monomer and having an         manufacture of paper and
 average nitrogen content of 14.9         paperboard in such an amount
 percent such that a 1 percent by         that the finished paper and
 weight aqueous solution has a minimum    paperboard will contain the
 viscosity of 600 centipoises at 75       additive at a level not in
 [deg]F, as determined by LVG-series      excess of 0.05 percent by
 Brookfield viscometer (or equivalent)    weight of dry fibers in the
 using a No. 2 spindle at 30 r.p.m.       finished paper and paperboard.

[[Page 198]]


Acrylamide-[beta]-                       For use only as a retention aid
 methacrylyloxyethyltrimethylammonium     and flocculant employed prior
 methyl sulfate copolymer resins          to the sheet-forming operation
 containing not more than 10 molar        in the manufacture of paper
 percent of [beta]-                       and paperboard.
 methacrylyloxyethyltrimethylammonium
 methyl sulfate and containing less
 than 0.2% of residual acrylamide
 monomer.
Acrylic acid, sodium salt copolymer      For use only in paper mill
 with polyethyleneglycol allyl ether      boilers.
 (CAS Reg. No. 86830-15-1).
Acrylic acid copolymer with 2-           For use only as a scale
 acrylamido-2-methylpropane-sulfonic      inhibitor prior to the sheet-
 acid (CAS Reg. No. 40623-75-4) and/or    forming operation in the
 its ammonium/alkali metal mixed salts.   manufacture of paper and
 The copolymer is produced by poly-       paperboard and used at a level
 merization of acrylic acid and 2-        not to exceed 1.0 kilogram
 acrylamido-2-methylpropane-sulfonic      (2.2 pounds) of copolymer per
 acid in a weight ratio of 60/40, such    907 kilograms (1 ton) of dry
 that a 28 percent by weight aqueous      paper and paperboard fibers.
 solution of the polymer has a
 viscosity of 75-150 centipoises at 25
 [deg]C as determined by LV-series
 Brookfield viscometer (or equivalent)
 using a No. 2 spindle at 60 r.p.m.
Acrylonitrile polymer, reaction product  For use only as a size promoter
 with ethylenediamine sulfate having a    and retention aid at a level
 nitrogen content of 22.5-25.0 percent    not to exceed 0.5 percent by
 (Kjeldahl dry basis) and containing no   weight of the dry paper and
 more than 0.075 percent monomer as       paperboard.
 ethylenediamine. The finished resin in
 a 24 percent by weight aqueous
 solution has a viscosity of 1,000-
 2,000 centipoises at 25 [deg]C as
 determined by LVT-series Brookfield
 viscometer using a No. 4 spindle at 50
 r.p.m. (or by other equivalent method).
Acrylonitrile polymer with styrene,      1. For use only as a sizing
 reaction product with ethylenediamine    material applied after the
 acetate, having a nitrogen content of    sheet-forming operation in the
 7.4-8.3 percent (Kjeldahl dry basis)     manufacture of paper and
 and containing no more than 0.25         paperboard in such amount that
 percent monomer as ethylenediamine.      the paper and paperboard will
                                          contain the additive at a
                                          level not in excess of 0.25
                                          percent by weight of the dry
                                          paper and paperboard.
                                         2. For use only as a sizing
                                          material applied prior to the
                                          sheet-forming operation in the
                                          manufacture of paper and
                                          paperboard in such amount that
                                          the paper and paperboard will
                                          contain the additive at a
                                          level not in excess of 1.0
                                          percent by weight of the dry
                                          paper and paperboard.
1-Alkenyl olefins, containing not less   For use only under the
 than 72 percent of C30 and higher        following conditions:
 olefins.                                1. In coatings for paper and
                                          paperboard with food of Types
                                          I, II, IV-B, and VII-B
                                          described in table 1 of
                                          paragraph (c) of this section
                                          under conditions of use E, F,
                                          and G described in table 2 of
                                          paragraph (c) of this section.
                                         2. In coatings for paper and
                                          paperboard with food of Type
                                          VIII described in table I of
                                          paragraph (c) of this section
                                          under conditions of use A
                                          through H described in table 2
                                          of paragraph (c) of this
                                          section.
(2-Alkenyl) succinic anhydrides          For use only as a sizing agent
 mixture, in which the alkenyl groups     employed prior to the sheet-
 are derived from olefins which contain   forming operation in the
 not less than 95 percent of C15-C21      manufacture of paper and
 groups.                                  paperboard and limited to use
                                          at a level not to exceed 1
                                          percent by weight of the
                                          finished dry paper and
                                          paperboard fibers.
Alkyl(C12-C20)methacrylatemethacrylic    For use only as stabilizers
 acid copolymers (CAS Reg. No. 27401-06-  employed prior to the sheet-
 5).                                      forming operation in the
                                          manufacture of paper and
                                          paperboard.
tert-Alkyl(C8-C16)mercaptans...........  For use only as polymerization-
                                          control agent.
Aluminum acetate.......................
2-Amino-2-methyl-1-propanol (CAS Reg.    For use as a dispersant for
 No. 124-68-5).                           pigment suspension at a level
                                          not to exceed 0.25 percent by
                                          weight of pigment. The
                                          suspension is used as a
                                          component of coatings for
                                          paper and paperboard under
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use E
                                          through G.

[[Page 199]]


Ammonium bis(N-ethyl-2-                  For use only as an oil and
 perfluoroalkylsulfonamido ethyl)         water repellant at a level not
 phosphates, containing not more than     to exceed 0.17 pound (0.09
 15% ammonium mono (N-ethyl-2-            pound of fluorine) per 1,000
 perfluoroalkylsulfonamido ethyl)         square feet of treated paper
 phosphates, where the alkyl group is     or paperboard of a sheet basis
 more than 95% C8 and the salts have a    weight of 100 pounds or less
 fluorine content of 50.2% to 52.8% as    per 3,000 square feet of paper
 determined on a solids basis.            or paperboard, and at a level
                                          not to exceed 0.5 pound (0.26
                                          pound of fluorine) per 1,000
                                          square feet of treated paper
                                          or paperboard having a sheet
                                          basis weight greater than 100
                                          lb. per 3,000 square feet as
                                          determined by analysis for
                                          total fluorine in the treated
                                          paper or paperboard without
                                          correction for any fluorine
                                          that might be present in the
                                          untreated paper or paperboard,
                                          when such paper or paperboard
                                          is used as follows:
                                         1. In contact, under conditions
                                          of use C, D, E, F, G, or H
                                          described in table 2 of
                                          paragraph (c) of this section,
                                          with nonalcoholic food.
                                         2. In contact with bakery
                                          products of Type VII, VIII,
                                          and IX described in table I of
                                          paragraph (c) of this section
                                          under good manufacturing
                                          practices of commercial and
                                          institutional baking.
Ammonium persulfate....................
Ammonium thiosulfate...................
Ammonium zirconium carbonate (CAS Reg.   For use only as an
 No. 32535-84-5) and its tartaric acid    insolubilizer for binders used
 adduct.                                  in coatings for paper and
                                          paperboard, and limited to use
                                          at a level not to exceed 2.5
                                          percent by weight of coating
                                          solids.
Ammonium zirconium citrate (CAS Reg.     For use as insolubilizers with
 No. 149564-62-5), ammonium zirconium     protein binders in coatings
 lactate-citrate (CAS Reg. No. 149564-    for paper and paperboard, at a
 64-7), ammonium zirconium lactate (CAS   level not to exceed 1.4
 Reg. No. 149564-63-6).                   percent by weight of coating
                                          solids.
Anionic polyurethane, produced by        For use only as a surface
 reacting the preliminary adduct formed   sizing agent at a level not to
 from the reaction of glyceryl            exceed 0.1 percent by weight
 monostearate and 2,4-                    of dry paper and paperboard.
 toluenediisocyanate with not more than
 10 mole percent N-methyldiethanolamine
 and not less than 90 mole percent
 dimethylolpropionic acid. The final
 product is a 15 to 20 percent by
 weight aqueous solution, having a
 Brookfield viscosity of 25 to 100
 centipoises at 24 [deg]C (75 [deg]F).
9,10-Anthraquinone (Chemical Abstracts   For use only as a pulping aid
 Service Registry No. 84-65-1) which      in the alkaline pulping of
 has a purity of not less than 98         lignocellulosic material at
 percent.                                 levels not to exceed 0.1
                                          percent by weight of the raw
                                          lignocellulosic material.
Aromatic petroleum hydrocarbon resin,    For use only as modifiers in
 hydrogenated (CAS Reg. No. 88526-47-     wax polymer blend coatings for
 0), produced by the catalytic            paper and paperboard at a
 polymerization of aromatic substituted   level not to exceed 50 weight-
 olefins from low boiling distillates     percent of the coating solids
 of cracked petroleum stocks with a       under conditions of use E, F,
 boiling point no greater than 220        and G identified in table 2 of
 [deg]C (428 [deg]F), and the             paragraph (c) of this section.
 subsequent catalytic reduction of the
 resulting aromatic petroleum
 hydrocarbon resin. The resin meets the
 following specifications: softening
 point 85 [deg]C (185 [deg]F) minimum,
 as determined by ASTM Method E 28-67
 (Reapproved 1982), ``Standard Test
 Method for Softening Point by Ring-and-
 Ball Apparatus,'' and aniline point 70
 [deg]C (158 [deg]F) minimum, as
 determined by ASTM Method D 611-82,
 ``Standard Test Methods for Aniline
 Point and Mixed Aniline Point of
 Petroleum Products and Hydrocarbon
 Solvents,'' which are incorporated by
 reference in accordance with 5 U.S.C.
 552(a) and 1 CFR part 51. Copies may
 be obtained from the American Society
 for Testing and Materials, 100 Barr
 Harbor Dr., West Conshohocken,
 Philadelphia, PA 19428-2959, or may be
 examined at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal--register/
 code--of--federal--regulations/ibr--
 locations.html..
Azo-bisisobutyronitrile................  For use only as polymerization
                                          catalyst.
1,2-Benzisothiazolin-3-one (CAS          For use only as a preservative
 Registry No. 2634-33-5).                 in paper coating compositions
                                          and limited to use at a level
                                          not to exceed 0.01 mg/in\2\
                                          (0.0016 mg/cm\2\) of the
                                          finished paper and paperboard.
Benzoyl peroxide.......................   Do.
N,N-Bis(2-hydroxyethyl)alkyl (C12-       For use only as an adjuvant to
 C18)amide.                               control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet
                                          forming operation.

[[Page 200]]


Bis(methoxymethyl)tetrakis-              For use only under the
 [(octadecyloxy)-methyl]melamine resins   following conditions:
 having a 5.8-6.5 percent nitrogen       1. As a water repellant
 content (CAS Reg. No. 68412-27-1).       employed prior to the sheet-
                                          forming operation in the
                                          manufacture of paper and
                                          paperboard in such amount that
                                          the finished paper and
                                          paperboard will contain the
                                          additive at a level not in
                                          excess of 1.6 percent by
                                          weight of the finished dry
                                          paper and paperboard fibers.
                                         2. The finished paper and
                                          paperboard will be used in
                                          contact with nonalcoholic
                                          foods only.
                                         3. As a water repellant
                                          employed after the sheet-
                                          forming operation in the
                                          manufacture of paper and
                                          paperboard in such amount that
                                          the finished paper and
                                          paperboard will contain the
                                          additive at a level not to
                                          exceed 1.6 percent by weight
                                          of the finished dry paper and
                                          paperboard fibers. The
                                          finished paper and paperboard
                                          will be used only in contact
                                          with food of Types I, II, IV-
                                          B, VI, VII-B, and VIII
                                          described in table 1 of
                                          paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS     For use only as an
 Reg. No. 52-51-7).                       antimicrobial/preservative in
                                          fillers, pigment slurries,
                                          starch sizing solutions, and
                                          latex coatings at levels not
                                          to exceed 0.01 percent by
                                          weight of those components.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
tert-Butyl hydroperoxide...............  For use only as polymerization
                                          catalyst.
tert-Butyl peroxide....................   Do.
Calcium isostearate....................  For use only with n-decyl
                                          alcohol as a stabilizing
                                          material for aqueous calcium
                                          stearate dispersions intended
                                          for use as components of
                                          coatings for paper and
                                          paperboard.
Carrageenan and salts of carrageenan as
 described in Sec.  Sec.   172.620 and
 172.626 of this chapter.
Castor oil, hydrogenated...............
Castor oil, sulfated, ammonium,
 potassium, or sodium salt.
Cellulose, regenerated.................
Chloracetamide.........................  For use only as polymerization-
                                          control agent.
Cobaltous acetate......................  For use only as polymerization
                                          catalyst.
Cumene hydroperoxide...................   Do.
Cyanoguanidine.........................  For use only:
                                         1. As a modifier for amino
                                          resins.
                                         2. As a fluidizing agent in
                                          starch and protein coatings
                                          for paper and paperboard.
n-Decyl alcohol........................  For use only with calcium
                                          isostearate as a stabilizing
                                          material for aqueous calcium
                                          stearate dispersions intended
                                          for use as components of
                                          coatings for paper and
                                          paperboard.
Dialdehyde guar gum....................  For use only as a wet-strength
                                          agent employed prior to the
                                          sheet-forming operation in the
                                          manufacture of paper and
                                          paperboard and used at a level
                                          not to exceed 1% by weight of
                                          the finished dry paper and
                                          paperboard fibers.
Dialdehyde locust bean gum.............   Do.
Dialkyl(C16-C18)carbamoyl chloride (CAS  For use as a sizing agent at a
 Reg. No. 41319-54-4) manufactured by     level not to exceed 0.2
 the reaction of secondary amines         percent by weight of the dry
 derived from fatty acids of animal or    fiber.
 vegetable sources with phosgene.
Diallyldimethyl ammonium chloride        For use only as a retention and/
 polymer with acrylamide and potassium    or drainage aid employed prior
 acrylate, produced by copolymerizing     to the sheet-forming
 either (1) diallyldimethyl ammonium      operations in the manufacture
 chloride and acrylamide in a weight      of paper and paperboard and
 ratio of 50/50, with 4.4 percent of      limited to use at a level not
 the acrylamide subsequently hydrolyzed   to exceed 0.05 percent by
 to potassium acrylate or (2)             weight of the finished paper
 polymerized diallyldimethyl ammonium     and paperboard.
 chloride, acrylamide and potassium
 acrylate (as acrylic acid) in a weight
 ratio of 50/47.8/2.2, respectively, so
 that the finished resin in a 1 percent
 by weight aqueous solution (active
 polymer) has a viscosity of more than
 22 centipoises at 22 [deg]C (72
 [deg]F) as determined by LVF series,
 Brookfield Viscometer using No. 1
 spindle at 60 RPM (or by other
 equivalent method) (CAS Reg. No. 25136-
 75-8).
Diallyldimethylammonium chloride with    For use only as a drainage and/
 acrylamide (CAS Reg. No. 26590-05-6).    or retention aid employed
 The copolymer is produced by             prior to the sheet-forming
 copolymerizing diallyldimethylammonium   operation in the manufacture
 chloride with acrylamide in a weight     of paper and paperboard and
 ratio of 50-50 so that the finished      limited to use at a level not
 resin in a 1 percent by weight aqueous   to exceed 0.05 percent by
 solution (active polymer) has a          weight of the finished paper
 viscosity of more than 22 centipoises    and paperboard.
 at 22 [deg]C (71.6 [deg]F), as
 determined by LVF-series Brookfield
 viscometer using a No. 1 spindle at 60
 r.p.m. (or by other equivalent method).

[[Page 201]]


Diallyldiethylammonium chloride polymer
 with acrylamide, and
 diallyldimethylammonium chloride,
 produced by copolymerizing acrylamide,
 diallyldiethylammonium chloride, and
 diallyldimethylammonium chloride,
 respectively, in the following weight
 ratios and having viscosities
 determined at 22 [deg]C, by LVF-series
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m. (or by other
 equivalent method), as follows:.
  1. Weight ratio: 50-2.5-47.5. The      For use only as a retention aid
   finished resin in a 1 percent by       employed prior to the sheet-
   weight aqueous solution has a          forming operation in the
   minimum viscosity of 22 centipoises.   manufacture of paper and
                                          paperboard and limited to use
                                          at a level not to exceed 0.05
                                          percent by weight of the
                                          finished paper and paperboard.
  2. Weight ratio: 25-2.5-72.5. The      For use only as a drainage and/
   finished resin in a 0.20 percent by    or retention aid employed
   weight aqueous solution has a          prior to the sheet-forming
   minimum viscosity of 20 centipoises.   operation in the manufacture
                                          of paper and paperboard and
                                          limited to use at a level not
                                          to exceed 0.075 percent by
                                          weight of the finished paper
                                          and paperboard.
  3. Weight ratio: 80-2.5-17.5. The      For use only as a drainage and/
   finished resin in a 0.30 percent by    or retention aid employed
   weight aqueous solution has a          prior to the sheet-forming
   minimum viscosity of 50 centipoises.   operation in the manufacture
                                          of paper and paperboard and
                                          limited to use at a level not
                                          to exceed 0.075 percent by
                                          weight of the finished paper
                                          and paperboard.
Diallyldiethylammonium chloride polymer  For use only as a retention aid
 with acrylamide, potassium acrylate,     employed prior to the sheet-
 and diallyldimethylammonium chloride.    forming operation in the
 The polymer is produced by               manufacture of paper and
 copolymerizing either: (1) acrylamide,   paperboard and limited to use
 diallyldiethylammonium chloride, and     at a level not to exceed 0.05
 diallyldimethylammonium chloride in a    percent by weight of the
 weight ratio of 50-2.5-47.5,             finished paper and paperboard.
 respectively, with 4.4 percent of the
 acrylamide subsequently hydrolyzed to
 potassium acrylate, or (2) acrylamide,
 potassium acrylate (as acrylic acid),
 diallyldiethylammonium chloride, and
 diallyldimethylammonium chloride in a
 weight ratio of 47.8-2.2-2.5-47.5, so
 that the finished resin in a 1 percent
 by weight aqueous solution has a
 minimum viscosity of 22 centipoises at
 22 [deg]C, as determined by LVF-series
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m. (or by other
 equivalent method).
Diallyldimethylammonium chloride         For use only as a dry and wet
 polymer with acrylamide, reaction        strength agent employed prior
 product with glyoxal, produced by        to the sheet-forming operation
 copolymerizing not less than 90 weight   in the manufacture of paper
 percent of acrylamide and not more       and paperboard in such an
 than 10 weight percent of                amount that the finished paper
 diallyldimethylammonium chloride,        and paperboard will contain
 which is then cross-linked with not      the additive at a level not in
 more than 30 weight percent of           excess of 2 percent by weight
 glyoxal, such that a 10 percent          of the dry fibers in the
 aqueous solution has a minimum           finished paper and paperboard.
 viscosity of 25 centipoises at 25
 [deg]C as determined by Brookfield
 viscometer Model RVF, using a No. 1
 spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS   For use as a preservative at a
 Reg. No.10222-01-2)..                    level not to exceed 100 parts
                                          per million in coating
                                          formulations and in component
                                          slurries and emulsions, used
                                          in the production of paper and
                                          paperboard and coatings for
                                          paper and paperboard.
2,5-Di-tert-butyl hydroquinone.........  For use only as an antioxidant
                                          for fatty based coating
                                          adjuvants provided it is used
                                          at a level not to exceed
                                          0.005% by weight of coating
                                          solids.
Diethanolamine.........................  For use only:
                                         1. As an adjuvant to control
                                          pulp absorbency and pitch
                                          content in the manufacture of
                                          paper and paperboard prior to
                                          the sheet-forming operation.
                                         2.In paper mill boilers.
Diethanolamine salts of mono- and bis    For use only as an oil and
 (1H,1H,2H,2H-perfluo roalkyl)            water repellant at a level not
 phosphates where the alkyl group is      to exceed 0.17 pound (0.09
 even-numbered in the range C8-C18 and    pound of fluorine) per 1,000
 the salts have a fluorine content of     square feet of treated paper
 52.4% to 54.4% as determined on a        or paperboard, as determined
 solids basis.                            by analysis for total fluorine
                                          in the treated paper or
                                          paperboard without correction
                                          for any fluorine which might
                                          be present in the untreated
                                          paper or paperboard, when such
                                          paper or paperboard is used in
                                          contact with nonalcoholic
                                          foods under the conditions of
                                          use described in paragraph (c)
                                          of this section, table 2,
                                          conditions of use (B) through
                                          (H).

[[Page 202]]


Diethyl(2-hydroxyethyl) methylammonium   For use only as a retention aid
 methyl sulfate, acrylate, polymer with   and drainage aid employed
 acrylamide, chemical abstract service    prior to the sheet-forming
 registry No. [26796-75-8] having 90-95   operation in the manufacture
 mole pct. acrylamide, a nitrogen         of paper and paperboard at a
 content of not more than 19.7 pct.       level not to exceed 0.15 pct.
 (Kjeldahl, dry basis), and a residual    by weight of finished dry
 acrylamide monomer content of not more   paper and paperboard fibers.
 than 0.1 pct. The finished polymer in
 a 1 pct. by weight aqueous solution
 has a minimum viscosity of 900
 centipoises at 25 [deg]C as determined
 by LVT-series Brookfield viscometer
 using a No. 2 spindle at 12 r.p.m. (or
 by equivalent method).
Diethylenetriamine.....................  For use only as a modifier for
                                          amino resins.
N,N-Diisopropanolamide of tallow fatty   For use only as an adjuvant to
 acids.                                   control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Dimethylamine-epichlorohydrin copolymer  For use only:
 in which not more than 5 mole-percent   1. As a retention aid employed
 of dimethylamine may be replaced by an   before the sheet-forming
 equimolar amount of ethylenediamine      operation in the manufacture
 and in which the ratio of total amine    of paper and paperboard and
 to epichlorohydrin does not exceed       limited to use at a level not
 1:1. The nitrogen content of the         to exceed 1 percent by weight
 copolymer shall be 9.4 to 10.8 weight    of the finished paper and
 percent on a dry basis and a 10          paperboard.
 percent by weight aqueous solution of   2. At the size press at a level
 the final product has a minimum          not to exceed 0.017 percent by
 viscosity of 5.0 centipoises at 25       weight of the finished paper
 [deg]C, as determined by LVT-series      and paperboard.
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m. (or by other
 equivalent method).
N-[(Dimethylamino)methyl]-acrylamide     For use only as a dry-strength
 polymer with acrylamide and styrene      agent employed prior to the
 having a nitrogen content of not more    sheet-forming operation in the
 than 16.9 percent and a residual         manufacture of paper and
 acrylamide monomer content of not more   paperboard and used at a level
 than 0.2 percent on a dry basis.         not to exceed 1 percent by
                                          weight of finished dry paper
                                          or paperboard fibers.
N,N'-Dioleoylethylenediamine...........
Diphenylamine..........................  For use only as an antioxidant
                                          for fatty based coating
                                          adjuvants provided it is used
                                          at a level not to exceed
                                          0.005% by weight of coating
                                          solids.
Dipropylene glycol.....................
Disodium salt of 1,4-dihydro-9,10-       For use only as a catalyst in
 dihydroxyanthracene (CAS Reg. No.        the alkaline pulping of
 73347-80-5).                             lignocellulosic materials at
                                          levels not to exceed 0.1
                                          percent by weight of the raw
                                          lignocellulosic materials.
N,N'-Distearoylethylenediamine.........
n-Dodecylguanidine acetate.............  For use only as an
                                          antimicrobial agent in paper
                                          and paperboard under the
                                          following conditions:

1. For contact only with nonalcoholic
 food having a pH above 5 and provided
 it is used at a level not to exceed
 0.4 percent by weight of the paper and
 paperboard.
2. For use in the outer ply of
 multiwall paper bags for contact with
 dry food of Type VIII described in
 table I of paragraph (c) of this
 section and provided it is used at a
 level of 0.8 percent by weight of the
 paper.
n-Dodecylguanidine hydrochloride.......  For use only as an
                                          antimicrobial agent in paper
                                          and paperboard under the
                                          following conditions:
                                         1. For contact only with
                                          nonalcoholic food having a pH
                                          above 5 and provided it is
                                          used at a level not to exceed
                                          0.4 percent by weight of the
                                          paper and paperboard.
                                         2. For use in the outer ply of
                                          multiwall paper bags for
                                          contact with dry food of Type
                                          VIII described in table I of
                                          paragraph (c) of this section
                                          and provided it is used at a
                                          level of 0.8 percent by weight
                                          of the paper.
Fatty acids derived from animal and
 vegetable fats and oils and salts of
 such acids, single or mixed, as
 follows:
 Aluminum.
 Ammonium.
 Calcium.
 Magnesium.
 Potassium.
 Sodium.
 Zinc.
Ferric chloride........................
Ferrous ammonium sulfate...............
Fish oil, hydrogenated.................
Fish oil, hydrogenated, potassium salt.
Furcelleran and salts of furcelleran as
 described in Sec.  Sec.   172.655 and
 172.660 of this chapter.
Glutaraldehyde (CAS Reg. No. 111-30-8).  For use only as an
                                          antimicrobial agent in pigment
                                          and filler slurries used in
                                          the manufacture of paper and
                                          paperboard at levels not to
                                          exceed 300 parts per million
                                          by weight of the slurry
                                          solids.

[[Page 203]]


Glyceryl lactostearate.................
Glyceryl mono-1,2-hydroxystearate......
Glyceryl monoricinoleate...............
Guar gum modified by treatment with      For use only as a retention aid
 [beta]-diethylamino- ethyl chloride      and/or drainage aid employed
 hydrochloride.                           prior to the sheet-forming
                                          operation in the manufacture
                                          of paper and paperboard.
Guar gum modified by treatment with not  For use only as a retention aid
 more than 25 weight percent of 2,3-      and/or internal size employed
 epoxypropyltri-methylammonium chloride   prior to the sheet-forming
 such that the finished product has a     operation in the manufacture
 maximum chlorine content of 4.5          of paper and paperboard, and
 percent, a maximum nitrogen content of   limited to use at a level: (1)
 3.0 percent, and a minimum viscosity     Not to exceed 0.15 percent by
 in 1-percent-by-weight aqueous           weight of the finished dry
 solution of 1,000 centipoises at 77      paper and paperboard fibers
 [deg]F, as determined by RV-series       intended for use in contact
 Brookfield viscometer (or equivalent)    with all types of foods,
 using a No. 3 spindle at 20 r.p.m.       except (2) not to exceed 0.30
                                          pct. by weight of the finished
                                          dried paper and paperboard
                                          fibers for use with
                                          nonalcoholic and nonfatty food
                                          of types identified under
                                          Types I, II, IV-B, VI-B, VII-
                                          B, and VIII of table I in par.
                                          (c) of this section.
N, N, N', N', N'', N''-Hexakis           For use only as a water-
 (methoxymethyl)-1,3,5-triazine-2,4,6-    repellent applied to the
 triamine polymer with stearyl alcohol,   surface of paper and
 [alpha]-octadecenyl-omega-               paperboard at levels not to
 hydroxypoly(oxy-1,2-ethanediyl), and     exceed 1 percent by weight of
 alkyl (C20+) alcohols (CAS Reg. No.      the finished dry paperboard
 130328-24-4).                            fibers. The finished paper and
                                          paperboard will be used in
                                          contact with aqueous foods
                                          under conditions of use B
                                          through G as described in
                                          table 2 of paragraph (c) of
                                          this section.
Hexamethylenetetramine.................  For use only as polymerization
                                          cross-linking agent for
                                          protein, including casein.
Hydroquinone and the monomethyl or       For use only as an inhibitor
 monoethyl ethers of hydroquinone.        for monomers.
Hydroxymethyl-5,5-dimethylhydantoin      For use only as a preservative
 (CAS Reg. No. 27636-82-4), mixture       in clay-type fillers at a
 with 1,3-bis(hydroxymethyl)-5,5-         level not to exceed a combined
 dimethylhydantoin (CAS Reg. No. 6440-    total of 1,200 milligrams/
 58-0).                                   kilograms hydroxymethyl-5,5-
                                          dimethylhydantoin and 1,3-
                                          bis(hydroxymethyl)-5,5-
                                          dimethylhydantoin in the
                                          filler.
Hydroxypropyl guar gum having a minimum  For use only as a dry strength
 viscosity of 5,000 centipoises at 25     and formation aid agent
 [deg]C., as determined by RV-series      employed prior to the sheet-
 Brookfield viscometer using a No. 4      forming operation in the
 spindle at 20 r.p.m. (or other           manufacture of paper and
 suitable method) and using a test        paperboard and used at a level
 sample prepared by dissolving 5 grams    not to exceed 1.5 percent by
 of moisture-free hydroxypropyl guar      weight of finished dry paper
 gum in 495 milliliters of a 70 percent   or paperboard fibers.
 by weight aqueous propylene glycol
 solution.
12-Hydroxystearic acid-polyethylene      For use only as a surfactant
 glycol block copolymers (CAS Reg. No.    for dispersions of
 70142-34-6) produced by the reaction     polyacrylamide retention and
 of polyethylene glycol (minimum          drainage aids employed prior
 molecular weight 200) with 12-           to the sheet forming operation
 hydroxystearic acid.                     in the manufacture of paper
                                          and paperboard.
Imidazolium compounds, 2-(C17 and C17-   For use only at a level not to
 unsaturated alkyl)-1-[2-(C18 and C18-    exceed 0.5 percent by weight
 unsaturated amido)ethyl]-4,5-dihydro-1-  of the dry paper and
 methyl, methyl sulfates (CAS Reg. No.    paperboard.
 72749-55-4)..
Isopropyl m- and p-cresols (thymol       For use only as an antioxidant
 derived).                                for fatty based coating
                                          adjuvants provided it is used
                                          as a level not to exceed
                                          0.005% by weight of coating
                                          solids.
Isopropyl peroxydicarbonate............  For use only as polymerization
                                          catalyst.
Japan wax..............................
Lanolin................................
Lauryl peroxide........................  For use only as polymerization
                                          catalyst.
Lauryl sulfate salts:
 Ammonium.
 Magnesium.
 Potassium.
 Sodium.
Lecithin, hydroxylated.................
Lignin sulfonate and its calcium,
 potassium, and sodium salts.
Maleic anhydride, polymer with ethyl     For use only as a deposit
 acrylate and vinyl acetate, hydrolyzed   control additive prior to the
 (CAS Reg. No. 113221-69-5) and/or its    sheet forming operation to
 ammonium, potassium, and sodium salts.   prevent scale buildup in the
                                          manufacture of paper and
                                          paperboard in contact with
                                          food, at a level not to exceed
                                          0.075 percent (as the acid) by
                                          weight of the dry paper and
                                          paperboard.
Methacrylic acid-acrylic acid copolymer  For use only as a boiler water
 (CAS Reg. No. 25751-21-7).               additive at a level not to
                                          exceed 50 parts per million in
                                          the boiler water.
N-methyldiallylamine hydrochloride       For use only as a retention
 polymer with epichlorohydrin having a    aid, flocculating agent, and
 nitrogen content of 4.8 to 5.9 percent   wet-strength agent employed in
 (Kjeldahl dry basis) such that a 20      the manufacture of paper and
 percent by weight aqueous solution has   paperboard prior to the sheet-
 a minimum viscosity of 30 centipoises    forming operation and limited
 and maximum viscosity of 100             to use at a level not to
 centipoises at 25 [deg]C, as             exceed 1.5 percent by weight
 determined by LVF Model Brookfield       of the dry paper and
 viscometer using a No. 1 spindle at 60   paperboard.
 r.p.m. (or equivalent method).

[[Page 204]]


Methyl naphthalene sulfonic acid-        For use only as an adjuvant to
 formaldehyde condensate, sodium salt.    control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
N-methyl-N-(tall oil acyl) taurine,      For use only to control scale
 sodium salt (CAS Reg. No. 61791-41-1).   formation in the manufacture
                                          of paper and paperboard prior
                                          to the sheetforming operation
                                          at a level not to exceed 0.015
                                          percent by weight of the dry
                                          paper and paperboard.
Mineral oil, white.....................
Mono-, di-, tri-(1-methyl-1-             For use only as an emulsifier
 phenylethyl)-phenol, ethoxylated,        for rosin based sizing at a
 sulfated, ammonium salt with an          level not to exceed 0.03
 average of 12 to 16 moles of ethylene    percent by weight of the
 oxide (CAS Reg. No. 68130-71-2).         finished dry paper and
                                          paperboard.
Monoglyceride citrate..................
Monoisopropanolamine (CAS Reg. No. 78-   For use as a dispersant for
 96-6).                                   titanium dioxide suspensions
                                          at a level not to exceed 0.68
                                          percent by weight of titanium
                                          dioxide. The finished paper
                                          and paperboard will be used in
                                          contact with all food types
                                          under conditions of use E
                                          through G described in table 2
                                          of paragraph (c) of this
                                          section.
Mustardseed oil, sulfated, ammonium,
 potassium, or sodium salt.
Naphthalene sulfonic acid-formaldehyde   For use only as an adjuvant to
 condensate, sodium salt.                 control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Nitrocellulose, 10.9-12.2% nitrogen....
Oleic acid, sulfated, ammonium,
 potassium, or sodium salt.
N-Oleoyl-N'-stearoylethylenediamine....
Oxystearin.............................
Paraformaldehyde.......................  For use only as setting agent
                                          for protein.
Pentanoic acid, 4,4-bis [(gamma-omega-   For use only as an oil and
 perfluoro-C8-20-alkyl)thio]              water repellent and used at a
 derivatives, compounds with              level not to exceed 8 pounds
 diethanolamine (CAS Reg. No. 71608-61-   per ton of the finished paper
 2).                                      or paperboard when such paper
                                          or paperboard is used in
                                          contact with nonalcoholic
                                          foods under conditions of use
                                          E through H described in table
                                          2 of paragraph (c) of this
                                          section.
Perfluoroalkyl acrylate copolymer (CAS   For use only as an oil and
 Reg. No. 92265-81-1) containing 35 to    water repellent at a level not
 40 weight percent fluorine, produced     to exceed 0.5 percent by
 by the copolymerization of               weight of the finished paper
 ethanaminium, N,N,N-trimethyl-2-[(2-     and paperboard in contact with
 methyl-1-oxo-2-propenyl)-oxy]-,          nonalcoholic foods under
 chloride; 2-propenoic acid, 2-methyl-,   conditions of use C, D, E, F,
 oxiranylmethyl ester; 2-propenoic        G, or H described in table 2
 acid, 2-ethoxyethyl ester; and 2-        of paragraph (c) of this
 propenoic acid, 2[[(heptadecafluoro-     section.
 octyl)sulfonyl] methyl amino]ethyl
 ester.
Perfluoroalkyl substituted phosphate     For use only as an oil and
 ester acids, ammonium salts formed by    water repellant at a level not
 the reaction of 2,2-bis[                 to exceed 0.44 percent
 ([gamma],[omega]-perfluoroC4-20          perfluoroalkyl actives by
 alkylthio) methyl]-1,3-propanediol,      weight of the finished paper
 polyphosphoric acid and ammonium         and paperboard in contact with
 hydroxide.                               non-alcoholic foods under
                                          condition of use H as
                                          described in table 2 of
                                          paragraph (c) of this section;
                                          and in contact with food of
                                          types III, IV-A, V, VII-A, and
                                          IX described in table 1 of
                                          paragraph (c) of this section
                                          under conditions of use C
                                          through G as described in
                                          table 2 of paragraph (c) of
                                          this section.
Petrolatum.............................  Complying with Sec.   178.3700
                                          of this chapter.
Petroleum asphalt, steam and vacuum      For use only as a component of
 refined to meet the following            internal sizing of paper and
 specifications: Softening point          paperboard intended for use in
 88[deg] C to 93[deg] C, as determined    contact only with raw fruits,
 by ASTM method D36-76, ``Standard Test   raw vegetables, and dry food
 Method for Softening Point of Bitumen    of the type identified under
 (Ring-and-Ball Apparatus);''             Type VIII of table 1 in
 penetration at 25[deg] C not to exceed   paragraph (c) of this section,
 0.3 mm, as determined by ASTM method     and provided that the asphalt
 D5-73 (Reapproved 1978), ``Standard      is used at a level not to
 Test Method for Penetration of           exceed 5% by weight of the
 Bituminous Materials,'' which are        finished dry paper and
 incorporated by reference (Copies may    paperboard fibers.
 be obtained from the American Society
 for Testing Materials, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--locations.html.); and
 maximum weight loss not to exceed 3%
 when distilled to 371[deg] C, nor to
 exceed an additional 1.1% when further
 distilled between 371[deg] C and
 thermal decomposition.
Petroleum wax, synthetic...............  Complying with Sec.   178.3720
                                          of this chapter.
Phenothiazine..........................  For use only as antioxidant in
                                          dry rosin size.
Phenyl acid phosphate..................  For use only as polymerization
                                          catalyst in melamine-
                                          formaldehyde modified alkyd
                                          coatings and limited to use at
                                          a level not to exceed 2% by
                                          weight of the coating solids.
Phenyl-[beta]-naphthylamine............  For use only as antioxidant in
                                          dry rosin size and limited to
                                          use at a level not to exceed
                                          0.4% by weight of the dry
                                          rosin size.

[[Page 205]]


Phosphoric acid esters and polyesters    For use as an adjuvant prior to
 (and their sodium salts) of              the sheet forming operation to
 triethanolamine formed by the reaction   control pitch and scale
 of triethanolamine with polyphosphoric   formation in the manufacture
 acid to produce a mixture of esters      of paper and paperboard
 having an average nitrogen content of    intended for use in contact
 1.5 percent and an average phosphorus    with food only of the types
 content of 32 percent (as PO4).          identified in paragraph (c) of
                                          this section, table 1, under
                                          Types I, IV, V, VII, VIII, and
                                          IX, and used at a level not to
                                          exceed 0.075 percent by weight
                                          of dry paper or paperboard
                                          fibers.
Poly[acrylamide-acrylic acid-N-          For use only as a drainage aid
 (dimethyl-aminomethyl)acryl- amide],     and retention aid employed
 produced by reacting 2.40 to 3.12        prior to the sheet-forming
 parts by weight of polyacrylamide with   operation in the manufacture
 1.55 parts dimethylamine and 1 part      of paper and paperboard for
 formaldehyde, and containing no more     use in contact with fatty
 than 0.2 percent monomer as acrylamide.  foods under conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2- For use only as a retention and
 hydroxypropyl acrylate) produced when    drainage aid employed prior to
 one mole of hydroxypropyl acrylate and   the sheet-forming operation in
 three moles of acrylic acid are          the manufacture of paper and
 reacted with three moles of              paperboard at a level not to
 ethylenimine and three moles of nitric   exceed 0.2 percent by weight
 acid, such that a 35 percent by weight   of dry paper or paperboard
 aqueous solution has a minimum           fiber.
 viscosity of 150 centipoises at 72
 [deg]F., as determined by RVF-series
 Brookfield viscometer (or equivalent)
 using a No. 2 spindle at 20 r.p.m.
Polyacrolein (1 part) -sodium bisulfite  For use only as an agent in
 (0.7 part) adduct, containing excess     modifying starches and starch
 bisulfite (ratio of excess bisulfite     gums used in the production of
 to adduct not to exceed 1.5 to 1).       paper and paperboard and
                                          limited to use at a level not
                                          to exceed 0.09 mg/in\2\ of the
                                          finished paper and paperboard.
Poly[acrylamide-acrylic acid-N-          For use only as a drainage aid,
 (dimethylaminomethyl) acrylamide]        retention aid, or dry-strength
 (C.A. Registry No. 53800-41-2),          agent employed prior to the
 produced by reacting 9.6-16.4 parts by   sheet-forming operation in the
 weight of polyacrylamide with 1.6        manufacture of paper and
 parts dimethylamine and 1 part           paperboard at a level not to
 formaldehyde, and containing no more     exceed 0.25 percent by weight
 than 0.2% monomer as acrylamide, such    of finished dry paper and
 that a 20% aqueous solution has a        paperboard fibers, when such
 minimum viscosity of 4,000 cP at 25      paper or paperboard is used in
 [deg]C., as determined by Brookfield     contact with fatty foods under
 viscometer model RVT, using a No. 5      conditions of use described in
 spindle at 20 r/min (or equivalent       paragraph (c) of this section,
 method).                                 table 2, conditions of use E,
                                          F, and G.
Polyamide-epichlorohydrin modified       For use only as a retention aid
 resin produced by reacting adipic acid   and flocculant employed prior
 with diethylene triamine to produce a    to the sheet-forming operation
 basic polyamide which is modified by     in the manufacture of paper
 reaction with formic acid and            and paperboard and used at a
 formaldehyde and further reacted with    level not to exceed 0.2
 epichlorohydrin in the presence of       percent dry resin by weight of
 ammonium hydroxide to form a water-      finished dry paper or
 soluble cationic resin having a          paperboard fibers.
 nitrogen content of 13-16 percent
 (Kjeldahl, dry basis) such that a 35
 percent by weight aqueous solution has
 a minimum viscosity of 75 centipoises
 at 25 [deg]C, as determined by
 Brookfield viscom eter using a No. 1
 spindle at 12 r.p.m.
Polyamide-epichlorohydrin water-soluble  For use only under the
 thermosetting resins [CAS Reg. No.       following conditions:
 68583-79-9] prepared by reacting        1. As a retention aid employed
 adipic acid with diethylenetriamine to   prior to the sheet-forming
 form a basic polyamide and further       operation in the manufacture
 reacting the polyamide with an           of paper and paperboard and
 epichlorohydrin and dimethylamine        limited to use at a level not
 mixture such that the finished resins    to exceed 0.12 percent by
 have a nitrogen content of 17.0 to       weight of dry paper or
 18.0 percent of a dry basis, and that    paperboard.
 a 30-percent-by-weight aqueous          2. The finished paper or
 solution has a minimum viscosity of      paperboard will be used in
 350 centipoises at 20 [deg]C, as         contact with food only of the
 determined by a Brookfield viscometer    types identified in paragraph
 using a No. 3 spindle at 30 r.p.m. (or   (c) of this section, table 1,
 equivalent method).                      under types I and IV-B and
                                          under conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use F and G.
Polyamide-epichlorohydrin water-soluble  For use only as a wet strength
 thermosetting resin (CAS Reg. No.        agent and/or retention aid
 96387-48-3) prepared by reacting N-      employed prior to the sheet-
 methyl-bis(3-aminopropyl) amine with     forming operation in the
 oxalic acid and urea to form a basic     manufacture of paper and
 polyamide and further reacting the       paperboard and used at a level
 polyamide with epichlorohydrin.          not to exceed 1.5 percent by
                                          weight of dry paper and
                                          paperboard fibers.
Polyamide-epichlorohydrin water-soluble  For use only in the manufacture
 thermosetting resins prepared by         of paper and paperboard under
 reacting adipic acid, isophthalic        conditions such that the
 acid, itaconic acid or dimethyl          resins do not exceed 1.5
 glutarate with diethylenetriamine to     percent by weight of the paper
 form a basic polyamide and further       or paperboard.
 reacting the polyamide with one of the
 following:
  Epichlorohydrin.
  Epichlorohydrin and ammonia mixture.
  Epichlorohydrin and sodium
   hydrosulfite mixture.
Polyamidoamine-ethyleneimine-            For use only as a retention aid
 epichlorohydrin resin prepared by        employed prior to the sheet-
 reacting hexanedioic acid, N-(2-         forming operation in the
 aminoethyl)-1,2-ethanediamine,           manufacture of paper and
 (chloromethyl)oxirane, ethyleneimine     paperboard at a level not to
 (aziridine), and polyethylene glycol,    exceed 0.12 percent resin by
 partly neutralized with sulfuric acid    weight of the finished dry
 (CAS Reg. No. 167678-45-7).              paper or paperboard.

[[Page 206]]


Polyamidol-epichlorohydrin modified      For use only as a wet strength
 resin produced by reacting glutaric      agent employed prior to the
 acid dimethyl ester with diethylene-     sheet-forming operation in the
 triamine to produce a basic polyamide    manufacture of paper and
 which is modified by reaction with       paperboard, and used at a
 formaldehyde and further reacted with    level not to exceed 2.5
 epicholorohydrin to form a water         percent by weight of dry paper
 soluble cationic resin having a          and paperboard fibers when
 nitrogen content of 10.9-11.9 percent    such paper or paperboard is
 and a chlorine content of 13.8-14.8      used in contact with food
 percent, on a dry basis, and a minimum   under conditions of use E
 viscosity, in 12.5 percent by weight     through G described in table 2
 aqueous solution, of 10 centipoises at   of paragraph (c) of this
 25 [deg]C, as determined by a            section.
 Brookfield Model LVF viscometer using
 a No. 1 spindle at 60 r.p.m. (or
 equivalent method).
Polyamine-epichlorohydrin resin          For use only as a flocculant,
 produced by the reaction of              drainage aid, formation aid,
 epichlorohydrin with monomethylamine     retention aid, or strength
 to form a prepoly mer and further        additive employed prior to the
 reaction of this prepolymer with         sheet-forming operation in the
 N,N,N',N'-tetramethylethylenediamine     manufacture of paper and
 such that the finished resin having a    paperboard, and used at a
 nitrogen content of 11.6 to 14.8         level not to exceed 0.12
 percent and a chlorine content of 20.8   percent by weight of dry paper
 to 26.4 percent and a minimum            and paperboard fibers.
 viscosity, in 25 percent by weight
 aqueous solution, of 500 centipoises
 at 25 [deg]C, as determined by LV-
 series Brookfield viscometer using a
 No. 2 spindle at 12 r.p.m. (or by
 other equivalent method).
Polyamine-epichlorohydrin resin          For use only as a clarifier in
 produced by the reaction of N,N-         the treatment of influent
 dimethyl-1,3-propanediamine with         water to be used in the
 epichlorohydrin and further reacted      manufacture of paper and
 with sulfuric acid, Chemical Abstracts   paperboard, and used at a
 Service Registry Number [27029-41-0],    level not to exceed 20 parts
 such that the finished resin has a       per million of the influent
 maximum nitrogen content of 14.4         water.
 percent (dry basis) and a minimum
 viscosity in 30 percent by weight
 aqueous solution (pH 4-6) of 50
 centipoises at 25 [deg]C, as
 determined by Brookfield LVT model
 viscometer, using a No. 1 spindle at
 12 r.p.m. (or equivalent method).
Polyamine-epichlorohydrin water-soluble  For use only as a wetstrength
 thermosetting resin produced by          agent and/or retention aid
 reacting epichlorohydrin with: (i)       employed prior to the sheet-
 polyamines comprising at least 95        forming operation in the
 percent by weight C4 to C6 aliphatic     manufacture of paper and
 diamines and/or their self-              paperboard, and used at a
 condensation products, and/or (ii)       level not to exceed 1 percent
 prepolymers produced by reacting 1,2-    by weight of dry paper and
 dichloroethane with the polyamines in    paperboard fibers.
 (i). The finished resin has a nitrogen
 content of 5.0 to 9.0 percent, a
 chlorine content of 18.0 to 35.0
 percent on a dry basis, and a minimum
 viscosity, in a 25 percent by weight
 aqueous solution, of 50 centipoises at
 20 [deg]C (68 [deg]F), as determined
 by Brookfield HAT model viscometer
 using a No. 1H spindle at 50 r.p.m.
 (or equivlent method).
Polyamine-epichlorohydrin water-soluble  For use only as a wet-strength
 thermosetting resin produced by          agent and/or retention aid
 reacting epichlorohydrin with: (i)       employed prior to the sheet-
 polyamines comprising at least 95        forming operation in the
 percent by weight C4 to C6 aliphatic     manufacture of paper and
 diamines and/or their seIf-              paperboard, and used at a
 condensation products and/or (ii)        level not to exceed 1 percent
 hexamethylenediamine, and/or (iii)       by weight of dry paper and
 bis(hexamethylene) triamine and higher   paperboard fibers.
 homologues, and/or (iv) prepolymers
 produced by reacting 1,2-
 dichloroethane with the polyamines in
 (i) and/or (ii) and/or (iii). The
 finished resin has a nitrogen content
 of 5.0 to 9.0 percent, a chlorine
 content of 18.0 to 35.0 percent on a
 dry basis, and a minimum viscosity, in
 a 25 percent by weight aqueous
 solution, of 50 centipoises at 20
 [deg]C (68 [deg]F), as determined by
 Brookfield HAT model viscometer using
 a No. 1H spindle at 50 r.p.m. (or
 equivalent method).
Polyamine-epichlorohydrin water soluble  For use only as a wet-strength
 thermosetting resin prepared by          agent and/or retention aid
 reacting hexamethylenediamine with 1,2-  employed prior to the sheet-
 di chloroethane to form a prepolymer     forming operation in the
 and further reacting this prepolymer     manufacture of paper and
 with epichlorohydrin. This resin is      paperboard, and used at a
 then reacted with nitrilotris            level not to exceed 1 percent
 (methylene-phosphonic acid),             by weight of dry paper and
 pentasodium salt, such that the          paperboard fibers.
 finished resin has a nitrogen content
 of 5.0-5.3 percent; a chlorine content
 of 29.7-31.3 percent; and a phosphorus
 content of 2.0-2.2 percent, on a dry
 basis, and a minimum viscosity, in 25
 percent by weight aqueous solution, of
 50 centipoises at 25 [deg]C., as
 determined on a Brookfield HAT model
 viscometer using a No. 1H spindle at
 50 r.p.m. (or equivalent method).

[[Page 207]]


Polyamine resin produced by the          For use only as a retention aid
 reaction of 1,2-dichloroethane with      and/or flocculent employed
 bis(hexamethylene)triamine and higher    prior to the sheet-forming
 homologues such that the finished        operation in the manufacture
 resin has a nitrogen content of 13.0-    of paper and paperboard and
 15.0 percent on a dry basis, and a       used at a level not to exceed
 minimum viscosity in 25-percent-by-      0.1 percent by weight of dry
 weight aqueous solution of 75            paper or paperboard fibers.
 centipoises at 25 [deg]C., as
 determined by Brookfield HAT model
 viscometer using a No. 1 spindle at 50
 r.p.m. (or equivalent method).
Polyaminoamide-epichlorohydrin modified  For use only as a wet-strength
 resin produced by reacting adipic acid   agent and/or retention aid
 with diethylenetriamine to produce a     employed prior to the sheet-
 polyamide which is modified by           forming operation in the
 reaction with diethylaminopropylamine    manufacture of paper and
 and further reacted with dichlor         paperboard, and used at a
 oethyl ether to form a polyamide         level not to exceed 0.5
 intermediate. This polyamide             percent by weight of the
 intermediate is then reacted with        finished dry paper and
 epichlorohydrin such that the finished   paperboard.
 resins have a nitrogen content of 10.9-
 12.4 percent (Kjeldahl, dry basis) and
 a minimum viscosity in 40 percent-by-
 weight aqueous solution of 250
 centipoises at 22 [deg]C, as
 determined by a Brookfield Model LVT
 viscometer using a No. 2 spindle at 30
 r.p.m. (or equivalent method).
Polybutene, hydrogenated; complying      For use only as provided in
 with the identity prescribed under       Sec.  Sec.   175.300, 178.3740
 Sec.   178.3740(b) of this chapter.      and 178.3860 of this chapter.
Poly(diallyldimethylammonium chloride)   For use only:
 (CAS Reg. No. 26062-79-3) produced by   1. As a pigment dispersant and/
 the polymerization of                    or retention aid prior to the
 (diallyldimethylammonium chloride) so    sheet-forming operation in the
 that the finished resin has a nitrogen   manufacture of paper and
 content of 8.660.4 percent on a dry weight basis     level not to exceed 10 pounds
 and a minimum viscosity in a 40          of active polymer per ton of
 percent by weight aqueous solution of    finished paper and paperboard.
 1,000 centipoises at 25 [deg]C (77      2. As a pigment dispersant in
 [deg]F), determined by LVF Model         coatings at a level not to
 Brookfield Viscometer using a No. 3      exceed 3.5 pounds of active
 spindle at 30 r.p.m. (or equivalent      polymer per ton of finished
 method). The level of residual monomer   paper and paperboard.
 is not to exceed 1 percent by weight
 of the polymer (dry basis).
Poly (diallyldimethylammonium chloride)  For use only as a flocculant
 (CAS Reg. No. 26062-79-3) produced by    employed prior to the sheet-
 the polymerization of                    forming operation in the
 diallyldimethylammonium chloride so      manufacture of paper and
 that the finished resin has a nitrogen   paperboard, and used at a
 content of 8.660.4 percent on a dry basis and a      (10 parts per million) of
 minimum viscosity in a 15 weight-        influent water.
 percent aqueous solution of 10
 centipoises at 25 [deg]C (77 [deg]F),
 as determined by LVF Model Brookfield
 viscometer using a No. 1 spindle at 60
 r/min (or equivalent method). The
 level of residual monomer is not to
 exceed 1 weight-percent of the polymer
 (dry basis).
Poly(1,2-dimethyl-5-vinylpyridinium      For use only as an adjuvant
 methyl sulfate) having a nitrogen        employed in the manufacture of
 content of 5.7 to 7.3 percent and a      paper and paperboard prior to
 sulfur content of 11.7 to 13.3 percent   the sheet-forming operation.
 by weight on a dry basis and having a
 minimum viscosity in 30-percent-by-
 weight aqueous solution of 2,000
 centipoises at 25 [deg]C., as
 determined by LV-series Brookfield
 viscometer (or equivalent) using a No.
 4 spindle at 60 r.p.m.
Polyester resin produced by reacting     For use only as a surface-
 dimethylolpropionic acid (CAS Registry   sizing compound applied after
 No. 4767-03-7) as a comonomer, at no     the sheet-forming operation in
 more than 30 percent by weight of        the manufacture of paper and
 total polymer solids in reaction with    paperboard and limited to use
 2,2-dimethyl-1,3-propanediol, phthalic   at levels not to exceed 0.1
 anhydride and isophthalic acid, such     percent by weight of finished
 that the polyester resin has a           dry paper or paperboard.
 viscosity of 200-600 centipoises at 80
 [deg]F as determined by a Brookfield
 RVT viscometer using a number 3
 spindle at 50 rpm (or equivalent
 method).
Polyethylene, oxidized; complying with   For use only as component of
 the identity prescribed in Sec.          coatings that contact food
 177.1620(a) of this chapter.             only of the type identified
                                          under Type VII-B of table 1 in
                                          paragraph (c) of this section,
                                          and limited to use at a level
                                          not to exceed 50 percent by
                                          weight of the coating solids.
Polyethyleneamine mixture produced when  For use only as a retention aid
 1 mole of ethylene dichloride, 1.05      employed prior to the sheet-
 moles of ammonia, and 2 moles of         forming operation in the
 sodium hydroxide are made to react so    manufacture of paper and
 that a 10 percent aqueous solution has   paperboard.
 a minimum viscosity of 40 centipoises
 at 77 [deg]F, as determined by
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m.
Polyethylene glycol (200) dilaurate....  For use only as an adjuvant
                                          employed in the manufacture of
                                          paper and paperboard prior to
                                          the sheet-forming operation.
Polyethylene glycol (400) dioleate.....
Polyethylene glycol (400) esters of
 coconut oil fatty acids.
Polyethylene glycol (600) esters of
 tall oil fatty acids.
Polyethylene glycol (400) monolaurate..
Polyethylene glycol (600) monolaurate..
Polyethylene glycol (400) monooleate...
Polyethylene glycol (600) monooleate...
Polyethylene glycol (400) monostearate.

[[Page 208]]


Polyethylene glycol (600) monostearate.
Polyethylene glycol (3,000)
 monostearate.
Polyethylenimine, produced by the        For use only as an adjuvant
 polymerization of ethylenimine.          employed prior to sheet
                                          formation in paper-making
                                          systems operated at a pH of
                                          4.5 or higher, and limited to
                                          use at a level not to exceed
                                          5% by weight of finished dry
                                          paper or paperboard fibers.
Poly(isobutene)/maleic anhydride         For use only as a surfactant
 adduct, diethanolamine reaction          for dispersions of
 product. The mole ratio of               polyacrylamide retention and
 poly(isobutene)/maleic anydride adduct   drainage aids employed prior
 to diethanolamine is 1:1.                to the sheet formation
                                          operation in the manufacture
                                          of paper and paperboard.
Polymethacrylic acid, sodium salt,       For use only as a coating
 having a viscosity in 30-percent-by-     adjuvant for controlling
 weight aqueous solution of 125-325       viscosity when used at a level
 centipoises at 25 [deg]C as determined   not to exceed 0.3% by weight
 by LV-series Brookfield viscometer (or   of coating solids.
 equivalent) using a No. 2 spindle at
 60 r.p.m.
Polymethacrylic acid, sodium salt,       For use only as a coating
 having a viscosity in 40-percent-by-     adjuvant for controlling
 weight aqueous solution of 400-700       viscosity when used at a level
 centipoises at 25 [deg]C, as             not to exceed 0.1% by weight
 determined by LV-series Brookfield       of coating solids.
 viscometer (or equivalent) using a No.
 2 spindle at 30 r.p.m.
Poly[(methylimino)(2-                    For use only as a retention aid
 hydroxytrimethylene)hydrochlo ride]      employed prior to the sheet-
 produced by reaction of 1:1 molar        forming operation in such an
 ratio of methylamine and                 amount that finished paper and
 epichlorohydrin so that a 31-percent     paperboard will contain the
 aqueous solution at 25[deg] C has a      additive at a level not in
 Stokes viscosity range of 2.5-4.0 as     excess of 1 percent by weight
 determined by ASTM method D1545-76       of the dry paper and
 (Reapproved; 1981), ``Standard Test      paperboard.
 Method for Viscosity of Transparent
 Liquids by Bubble Time Method,'' which
 is incorporated by reference. Copies
 may be obtained from the American
 Society for Testing Materials, 100
 Barr Harbor Dr., West Conshohocken,
 Philadelphia, PA 19428-2959, or may be
 examined at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal--register/
 code--of--federal--regulations/ibr--
 locations.html..
Poly[oxyethylene (dimethyliminio)        For use only to improve dry-
 ethylene (dimethyliminio) ethylene       strength of paper and
 dichloride] produced by reacting         paperboard and as a retention
 equimolar quantities of N,N,N,N-         and drainage aid employed
 tetramethylethylene-diamine and          prior to the sheet-forming
 dichlorethyl ether to yield a solution   operation in the manufacture
 of the solid polymer in distilled        of paper and paperboard and
 water at 25[deg] C with a reduced        limited to use at a level not
 viscosity of not less than 0.15          to exceed 0.1 percent by
 deciliter per gram as determined by      weight of the finished dry
 ASTM method D1243-79, ``Standard Test    paper and paperboard fibers.
 Method for -Dilute Solution Viscosity
 of Vinyl Chloride Polymers,'' which is
 incorporated by reference. Copies may
 be obtained from the American Society
 for Testing Materials, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--locations.html.). The
 following formula is used for
 determining reduced viscosity:.
  Reduced viscosity in terms of
   deciliters per gram=(t-t0)/(t-C),
  where:
  t=Solution efflux time
  to=Water efflux time
  C=Concentration of solution in terms
   of grams per deciliter
Polypropylene glycol (minimum molecular
 weight 1,000).
Potassium persulfate...................
2-Propenoic acid, telomer with sodium 2- For use only as a deposit
 methyl-2-[(1-oxo-2-propenyl)amino]-1-    control additive employed
 propane sulfonate and sodium             prior to the sheet forming
 phosphinate (CAS Reg. No. 110224-99-2).  operation in the manufacture
                                          of paper and paperboard and at
                                          a level not to exceed 0.15
                                          percent by weight of the dry
                                          paper and paperboard.
Propylene glycol alginate..............
Protein hydrolysate from animal hides
 or soybean protein condensed with
 oleic and/or stearic acid.
Rapeseed oil, sulfated ammonium,
 potassium, or sodium salt.
Ricebran oil, sulfated ammonium,
 potassium, or sodium salt.
Rosin and rosin derivatives............  As provided in Sec.   178.3870
                                          of this chapter.

[[Page 209]]


Siloxanes (silicones), dimethyl,         For use only as a component of
 isopropyl methyl, methyl 1-methyl-C9-    polyolefin coatings with Sec.
 49-alkyl (CAS Reg. No. 144635-08-5).      177.1520 of this chapter at a
                                          level not to exceed 3 percent
                                          by weight. The finished
                                          coating will be used only for
                                          paper and paperboard that
                                          contact food of types VI-A and
                                          VI-B of table 1 in paragraph
                                          (c) of this section, and under
                                          conditions of use C, D, and E,
                                          as described in table 2 in
                                          paragraph (c) of this section,
                                          with a maximum hot fill
                                          temperature of 200 [deg]F (94
                                          [deg]C).
Silver chloride-coated titanium dioxide  For use only as a preservative
                                          in polymer latex emulsions at
                                          a level not to exceed 2.2
                                          parts per million (based on
                                          silver ion concentration) in
                                          the dry coating.
Sodium carboxymethyl guar gum having a   For use only as a dry-strength
 minimum viscosity of 2,700 centipoises   and formation-aid agent
 at 25 [deg]C after 24 hours as           employed prior to the sheet-
 determined by RV-series Brookfield       forming operation in the
 viscometer (or equivalent) using a No.   manufacture of paper and
 4 spindle at 20 r.p.m. and using a       paperboard and used at a level
 test sample prepared by dissolving 8     not to exceed 1% by weight of
 grams of sodium carboxymethyl guar gum   finished dry paper or
 in 392 milliliters of 0.2-percent-by-    paperboard fibers.
 weight aqueous sodium o-phenylphenate
 solution.
Sodium dioctyl sulfosuccinate..........
Sodium formaldehyde sulfoxylate........  For use only as polymerization
                                          catalyst.
Sodium hypochlorite....................
Sodium N-methyl-N-oleyltaurate.........  For use only as an adjuvant to
                                          control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Sodium nitrite.........................  For use only:
                                         1. At levels not to exceed 0.2%
                                          by weight of lubricants or
                                          release agents applied at
                                          levels not to exceed 1 lb. per
                                          ton of finished paper or
                                          paperboard.
                                         2. As an anticorrosion agent at
                                          levels not to exceed 0.2% by
                                          weight of wax emulsions used
                                          as internal sizing in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Sodium persulfate......................
Sodium polyacrylate....................  For use only:
                                         1. As a thickening agent for
                                          natural rubber latex coatings,
                                          provided it is used at a level
                                          not to exceed 2 percent by
                                          weight of coating solids.
                                         2. As a pigment dispersant in
                                          coatings at a level not to
                                          exceed 0.25 percent by weight
                                          of pigment.
Sodium poly(isopropenylphosphonate)      For use only in paper mill
 (CAS Reg. No. 118632-18-1).              boilers.
Sodium zinc potassium polyphosphate      For use only as a pigment
 (CAS Reg. No. 65997-17-3).               dispersant in coatings at a
                                          level not to exceed 1 percent
                                          by weight of pigment.
Sperm oil, sulfated, ammonium,
 potassium, or sodium salt.
Stannous oleate........................
Stearyl-2-lactylic acid and its calcium
 salt.
Styrene-butadiene copolymers produced
 by copolymerizing styrene-butadiene
 with one or more of the monomers:
 acrylamide, acrylic acid, fumaric
 acid, 2-hydroxyethyl acrylate,
 itaconic acid, methacrylic acid, and N-
 methylolacrylamide (CAS Reg. No. 53504-
 31-7). The finished copolymers shall
 contain not more than 10 weight
 percent of total polymer units derived
 from acrylic acid, fumaric acid, 2-
 hydroxyethyl acrylate, itaconic acid,
 and methacrylic acid, and shall
 contain not more than 3 weight percent
 of total polymer units derived from N-
 methylolacrylamide, and shall contain
 not more than 2 weight percent of
 polymer units derived from acrylamide..
Styrene-maleic anhydride copolymer,      For use only as a surface size
 amidated, ammonium sodium salt;          at a level not to exceed 1
 having, in a 25 percent by weight        percent by weight of paper or
 aqueous solution at pH 8.8, a minimum    paperboard substrate.
 viscosity of 600 centipoises at 25
 [deg]C as determined by Brookfield
 model LVT viscometer using a No. 3
 spindle at 60 r.p.m. (or equivalent
 method).
Styrene-maleic anhydride copolymer,      For use only:
 sodium salt (minimum molecular weight   1. As a coating thickening
 30,000).                                 agent at a level not to exceed
                                          1% by weight of coating
                                          solids.
                                         2. As surface size at a level
                                          not to exceed 1% by weight of
                                          paper or paperboard substrate.
Styrene-methacrylic acid copolymer,      For use only as a coating
 potassium salt (minimum molecular        thickening agent at a level
 weight 30,000).                          not to exceed 1% by weight of
                                          coating solids.

[[Page 210]]


Synthetic wax polymer prepared by the    For use only as a component of
 catalytic po lymerization of alpha       petroleum wax and/or synthetic
 olefins such that the polymer has a      petroleum wax complying with
 maximum iodine number of 18 and a        Sec.   178.3710 or Sec.
 minimum number average molecular         178.3720 of this chapter at
 weight of 2,400.                         levels not to exceed 5 percent
                                          by weight of the wax:
                                         1. Under conditions of use F
                                          and G described in table 2 of
                                          paragraph (c) of this section
                                          for all foods.
                                         2. Under conditions of use E
                                          described in table 2 of
                                          paragraph (c) of this section
                                          for food Types I, II, IV-B,
                                          VI, VII-B and VIII as
                                          described in table 1 of
                                          paragraph (c) of this section.
Tallow.................................
Tallow alcohol.........................
Tallow alcohol, hydrogenated...........
Tallow fatty acid, hydrogenated........
Tallow hydrogenated....................
Tallow sulfated, ammonium, potassium,
 or sodium salt.
Tetraethylenepentamine.................  For use only as a modifier for
                                          amino resins.
1,4,4a,9a-Tetrahydro-9, 10-              For use only as a catalyst in
 anthracenedione (CAS Reg. No. 56136-14-  the alkaline pulping of
 2).                                      lignocellulosic materials at
                                          levels not to exceed 0.1
                                          percent by weight of the raw
                                          lignocellulosic materials.
N,N,N', N'-Tetramethylethylenediamine    For use only as a flocculent,
 polymer with bis-(2-chloroethyl)         drainage aid or retention aid
 ether, first reacted with not more       employed prior to the sheet
 than 5 percent by weight 1-chloro-2,3-   forming operation in the
 epoxypropane and then reacted with not   manufacture of paper and
 more than 5 percent by weight poly       paperboard and limited to use
 (acrylic acid) such that a 50 percent    at a level not to exceed 0.2
 by weight aqueous solution of the        percent by weight of the
 product has a nitrogen content of 4.7-   finished dry paper and
 4.9 percent and viscosity of 350-700     paperboard fibers.
 centipoises at 25 [deg]C as determined
 by LV series Brookfield viscometer
 using a No. 2 spindle at 60 r.p.m. (or
 by other equivalent method).
Tetrasodium N- (1,2-dicarboxyethyl) - N  For use only as an emulsifier
 - octadecylsulfo-succinamate.            in aqueous dispersions of
                                          rosin sizes complying with
                                          Sec.   178.3870(a)(4) of this
                                          chapter and limited to use
                                          prior to the sheet-forming
                                          operation in the manufacture
                                          of paper and paperboard at a
                                          level not to exceed 0.02 pct
                                          by weight of finished paper
                                          and paperboard.
Triethanolamine........................  For use only to adjust pH
                                          during the manufacture of
                                          amino resins permitted for use
                                          as components of paper and
                                          paperboard.
Triethylene glycol adipic acid           For use only as a curl-control
 monoester produced by reacting           agent at a level not to exceed
 equimolar quantities of triethylene      2% by weight of coated or
 glycol and adipic acid.                  uncoated paper and paperboard.
Triethylenetetramine...................  For use only as a modifier for
                                          amino resins.
1,3,5-Triethylhexahydro-1,3,5-triazine   For use only as an
 (CAS Registry No. 7779-27-3).            antimicrobial agent for
                                          coating, binder, pigment,
                                          filler, sizing, and similar
                                          formulations added prior to
                                          the heat drying step in the
                                          manufacture of paper and
                                          paperboard and limited to use
                                          at a level between 0.05 and
                                          0.15 percent by weight of the
                                          formulation.
Undecafluorocyclohexanemethanol ester    For use only as an oil
 mixture of dihydrogen phosphate,         repellent at a level not to
 compound with 2,2' iminodiethanol        exceed 0.087 lb (0.046 lb of
 (1:1); hydrogen phosphate, compound      fluorine) per 1,000 ft\2\ of
 with 2,2'-iminodiethanol (1:1); and      treated paper or paperboard,
 P,P'-dihydrogen pyrophosphate,           as determined by analysis for
 compound with 2,2'-iminodiethanol        total fluorine in the treated
 (1:2); where the ester mixture has a     paper or paperboard without
 fluorine content of 48.3 pct to 53.1     correction for any fluorine
 pct as determined on a solids basis.     which might be present in the
                                          untreated paper or paperboard,
                                          when such paper or paperboard
                                          is used in contact with food
                                          only of the types identified
                                          in paragraph (c) of this
                                          section, table 1, under Types
                                          IVA, V, VIIA, VIII, and IX,
                                          and under the conditions of
                                          use B through G described in
                                          table 2 of paragraph (c) of
                                          this section.
Viscose rayon fibers...................
Wax, petroleum.........................  Complying with Sec.   178.3710
                                          of this chapter.
Xanthan gum, conforming to the identity  For use only at a maximum level
 and specifications prescribed in Sec.    of 0.125 percent by weight of
  172.695 of this chapter, except that    finished paper as a suspension
 the residual isopropyl alcohol shall     aid or stabilizer for aqueous
 not exceed 6,000 parts per million.      pigment slurries employed in
                                          the manufacture of paper and
                                          paperboard.
Xylene sulfonic acid-formaldehyde        For use only as an adjuvant to
 condensate, sodium salt.                 control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Zeolite Na-A (CAS Reg. No. 68989-22-0).  For use as a pigment extender
                                          at levels not to exceed 5.4
                                          percent by weight of the
                                          finished paper and paperboard.
Zinc formaldehyde sulfoxylate..........  For use only as polymerization
                                          catalyst.
Zinc octoate...........................
Zirconium oxide........................  For use only as a component of
                                          waterproof coatings where the
                                          zirconium oxide is present at
                                          a level not to exceed 1
                                          percent by weight of the dry
                                          paper or paperboard fiber and
                                          where the zirconium oxide is
                                          produced by hydrolysis of
                                          zirconium acetate.
------------------------------------------------------------------------


[[Page 211]]

    (b) Substances identified in paragraphs (b) (1) and (2) of this 
section may be used as components of the food-contact surface of paper 
and paperboard, provided that the food-contact surface of the paper or 
paperboard complies with the extractives limitations prescribed in 
paragraph (c) of this section.
    (1) Substances identified in Sec.  175.300(b)(3) of this chapter 
with the exception of those identified in paragraphs (b)(3) (v), (xv), 
(xx), (xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of 
this section.
    (2) Substances identified in this paragraph (b)(2) follow:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
Acrylamide copolymerized with ethyl
 acrylate and/or stryene and/or
 methacrylic acid, subsequently reacted
 with formaldehyde and butyl alcohol.
Acrylamide copolymerized with ethylene   For use only as coatings or
 and vinyl chloride in such a manner      components of coatings.
 that the finished copolymers have a
 minimum weight average molecular
 weight of 30,000 and contain not more
 than 3.5 weight percent of total
 polymer units derived from acrylamide,
 and in such a manner that the
 acrylamide portion may or may not be
 subsequently partially hydrolyzed.
2-Acrylamido-2-methyl-propanesulfonic    For use only in coatings at a
 acid, homopolymer, sodium salt (CAS      level not to exceed 0.01 mg/
 Reg. No. 35641-59-9).                    in\2\
Acrylic and modified acrylic polymers..  Complying with Sec.   177.1010
                                          of this chapter.
Acrylic copolymers produced by
 copolymerizing 2 or more of the
 acrylate monomers butyl acrylate,
 ethyl acrylate, ethyl methacrylate,
 methyl acrylate, methyl methacrylate,
 and n-propyl methacrylate, or produced
 by copolymerizing one or more of such
 acrylate monomers together with one or
 more of the monomers acrylic acid,
 acrylonitrile, butadiene, 2-ethyl-
 hexyl acrylate, fumaric acid, glycidyl
 methacrylate, n-hexyl-methacrylate,
 itaconic acid, methacrylic acid,
 styrene, vinyl acetate, vinyl
 chloride, and vinylidene chloride. The
 finished copolymers shall contain at
 least 50 weight percent of polymer
 units derived from one or more of the
 monomers butyl acrylate, ethyl
 acrylate, ethyl methacrylate, methyl
 acrylate, methyl methacrylate, and n-
 propyl methacrylate; and shall contain
 not more than 5 weight percent of
 total polymer units derived from
 acrylic acid, fumaric acid, glycidyl
 methacrylate, n-hexyl methacrylate,
 itaconic acid, and methacrylic acid.
 The provision limiting the finished
 acrylic copolymers to not more than 5
 units derived from acrylic acid,
 fumaric acid, glycidyl methacrylate, n-
 hexyl methacrylate, itaconic acid, and
 methacrylic acid is not applicable to
 finished acrylic copolymers used as
 coating adjuvants at a level not
 exceeding 2 weight percent of total
 coating solids.
Alkyl mono- and disulfonic acids,        For use only:
 sodium salts (produced from n-alkanes   1. As emulsifiers for
 in the range of C10-C18 with not less    vinylidene chloride copolymer
 than 50 percent C14-C16)..               coatings and limited to use at
                                          levels not to exceed 2 percent
                                          by weight of the coating
                                          solids.
                                         2. As emulsifiers for
                                          vinylidene chloride copolymer
                                          or homopolymer coatings at
                                          levels not to exceed a total
                                          of 2.6 percent by weight of
                                          coating solids. The finished
                                          polymer contacts food only of
                                          types identified in paragraph
                                          (c) of this section, table 1,
                                          under Types I, II, III, IV, V,
                                          VIA, VIB, VII, VIII, and IX
                                          and under conditions of use E,
                                          F, and G described in table 2
                                          of paragraph (c) of this
                                          section.
2-Bromo-4'-hydroxyacetophenone.........  For use only as a preservative
                                          for coating formulations,
                                          binders, pigment slurries, and
                                          sizing solutions at a level
                                          not to exceed 0.006 percent by
                                          weight of the coating,
                                          solution, slurry or emulsion.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
Butylbenzyl phthalate..................  Complying with Sec.   178.3740
                                          of this chapter.
Butyl oleate, sulfated, ammonium,
 potassium, or sodium salt.
Butyraldehyde..........................
Captan (N-trichloromethylmercapto-4-     For use only as a mold- and
 cyclohexene-1, 2-dicarboximide).         mildew-proofing agent in
                                          coatings intended for use in
                                          contact with food only of the
                                          types identified in paragraph
                                          (c) of this section, table 1,
                                          under Type I, II, VI-B, and
                                          VIII.

[[Page 212]]


Castor Oil, polyoxyethylated (42 moles   For use only as an emulsifier
 ethylene oxide).                         in nitrocellulose coatings for
                                          paper and paperboard intended
                                          for use in contact with food
                                          only of the types identified
                                          in paragraph (c) of this
                                          section, table 1, under Types
                                          IV A, V, VII A, VIII, and IX;
                                          and limited to use at a level
                                          not to exceed 8 percent by
                                          weight of the coating solids.
1-(3-Chloroallyl)-3,5,7-triaza-1-        For use only:
 azoniaadamantane chloride (CAS Reg.     1. As a preservative at a level
 No. 4080-31-3).                          of 0.3 weight percent in
                                          latexes used as pigment
                                          binders in paper and
                                          paperboard intended for use in
                                          contact with nonacidic,
                                          nonalcoholic food and under
                                          the conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
                                         2. As a preservative at a level
                                          not to exceed 0.07 weight
                                          percent in latexes and 0.05
                                          weight percent in pigment
                                          slurries used as components of
                                          coatings for paper and
                                          paperboard intended for use in
                                          contact with food.
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only:
 (CAS Reg. No. 26172-55-4) and 2-methyl- 1. As an antimicrobial agent
 4-isothiazolin-3-one (CAS Reg. No.       for polymer latex emulsions in
 2682-20-4) mixture at a ratio of 3       paper coatings at a level not
 parts to 1 part, manufactured from       to exceed 50 parts per million
 methyl-3-mercaptopropionate (CAS Reg.    (based on isothiazolone active
 No. 2935-90-2). The mixture may          ingredients) in the coating
 contain magnesium nitrate (CAS Reg.      formulation.
 No. 10377-60-3) at a concentration      2. As an antimicrobial agent
 equivalent to the isothiazolone active   for finished coating
 ingredients (weight/weight).             formulations and for additives
                                          used in the manufacture of
                                          paper and paperboard including
                                          fillers, binders, pigment
                                          slurries, and sizing solutions
                                          at a level not to exceed 25
                                          parts per million (based on
                                          isothiazolone active
                                          ingredients) in the coating
                                          formulations and additives.
Copper 8-quinolinolate.................  For use only as preservative
                                          for coating formulations.
Cyclized rubber produced when natural    For use only in coatings for
 pale crepe rubber dissolved in phenol    paper and paperboard intended
 is catalytically cyclized so that the    for use in contact with food
 finished cyclized rubber has a melting   only of the types identified
 point of 145 [deg]C to 155 [deg]C as     in paragraph (c) of this
 determined by ASTM method E28-67         section, table 1, under Types
 (Reapproved 1982), ``Standard Test       VIII and IX.
 Method for Softening Point by Ring-and-
 Ball Apparatus,'' which is
 incorporated by reference (Copies may
 be obtained from the American Society
 for Testing Materials, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--locations.html.), and
 contains no more than 4000 ppm of
 residual-free phenol as determined by
 a gas liquid chromatographic procedure
 titled ``Determination of Free Phenol
 in Cyclized Rubber Resin,'' which is
 incorporated by reference. Copies are
 available from the Center for Food
 Safety and Applied Nutrition (HFS-
 200), Food and Drug Administration,
 5100 Paint Branch Pkwy., College Park,
 MD 20740, or available for inspection
 at the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--locations.html..
1,2-Dibromo-2,4-dicyanobutane (CAS Reg.  For use only as a preservative
 No. 35691-65-7).                         at levels not more than 0.05
                                          weight percent and not less
                                          than 0.01 weight percent: in
                                          latexes used as pigment
                                          binders in coatings; in
                                          pigment slurries used in
                                          coatings; and/or in coatings
                                          themselves. The total level of
                                          the preservative in the
                                          finished coating shall not
                                          exceed 0.04 weight percent of
                                          the finished coating solids.
Dibutyl phthalate......................
Dibutyl sebacate.......................
Di(C7,C9-alkyl) adipate................  Complying with Sec.   178.3740
                                          of this chapter.
Dicyclohexyl phthalate.................
Diethylene glycol dibenzoate (CAS Reg.   For use only as a plasticizer
 No. 120-55-8).                           for polyvinyl acetate coatings
                                          at a level not to exceed 5
                                          percent by weight of the
                                          coating solids under
                                          conditions described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use E,
                                          F, and G.
Diethylene glycol ester of the adduct
 of terpene and maleic anhydride.
Dihydroxy dichlorodiphenyl methane.....  For use only as preservative
                                          for coating formulations.
Dimethylpolysiloxane, 100 centistokes
 viscosity.
Dimethylpolysiloxane-beta-phenylethyl
 methyl polysiloxane copolymer (2:1),
 200 to 400 centistokes viscosity.

[[Page 213]]


N,N'-Diphenyl-p-phenylenediamine.......  For use only as polymerization
                                          inhibitor in 2-sulfoethyl
                                          methacrylate, sodium salt.
Dipropylene glycol dibenzoate (CAS Reg.  1. For use only as a
 No. 27138-31-4).                         plasticizer for polyvinyl
                                          acetate coatings at a level
                                          not to exceed 5 percent by
                                          weight of the coating solids
                                          under conditions described in
                                          paragraph (c) of this section,
                                          table 2, condition of use E.
                                         2. For use only as a
                                          plasticizer for polyvinyl
                                          acetate coatings at a level
                                          not to exceed 10 percent by
                                          weight of the coating solids
                                          under conditions described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use F
                                          and G.
Disodium N-octadecylsulfosuccinamate...  For use only as an emulsifier
                                          in resin latex coatings and
                                          limited to use at a level not
                                          to exceed 0.05% by weight of
                                          the coating solids.
EDTA (ethylenediaminetetraacetic acid)
 and its sodium and/or calcium salts.
Ethanedial, polymer with tetrahydro-4-   For use only as an
 hydroxy-5-methyl-2(1H)pyrimidinone,      insolubilizer for starch-based
 propoxylated (CAS Reg. No. 118299-90-    coatings and limited to use at
 4).                                      a level not to exceed 5.0
                                          percent by weight of the
                                          coating.
Ethylene-acrylic acid copolymers
 produced by the copolymerization of
 ethylene and acrylic acid and/or their
 partial ammonium salts. The finished
 copolymer shall contain no more than
 25 weight percent of polymer units
 derived from acrylic acid and no more
 than 0.35 weight percent of residual
 monomeric acrylic acid, and have a
 melt index not to exceed 350 as
 determined by ASTM method D1238-82,
 ``Standard Test Method for Flow Rates
 of Thermoplastics by Extrusion
 Plastometer,'' which is incorporated
 by reference. Copies may be obtained
 from the American Society for Testing
 Materials, 100 Barr Harbor Dr., West
 Conshohocken, Philadelphia, PA 19428-
 2959, or may be examined at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--locations.html..
Formaldehyde...........................  For use only as preservative
                                          for coating formulations.
Glyoxal................................  For use only as an
                                          insolubilizing agent in starch-
                                           and protein-based coatings
                                          that contact nonalcoholic
                                          foods, and limited to use at a
                                          level not to exceed 6 percent
                                          by weight of the starch or
                                          protein fraction of the
                                          coating solids.
Glyceryl monobutyl ricinoleate.........
Hydroxymethyl derivatives (mixture of    For use only as a comonomer in
 mono and poly) of [N-(1, 1-dimethyl-3-   polyvinyl acetate latex
 oxobutyl) acrylamide] produced by        coatings and limited to use at
 reacting 1 mole of the [N-(1,1-          a level not to exceed 1
 dimethyl-3-oxobutyl) acrylamide] with    percent by weight of dry
 3 moles of formaldehyde such that the    polymer solids.
 finished product has a maximum
 nitrogen content of 6.2 percent and a
 maximum hydroxyl content of 15 percent
 by weight on a dry basis.
Isobutyl oleate, sulfated, ammonium,
 potassium, or sodium salt.
Maleic anhydride adduct of butadiene-
 styrene copolymer.
[alpha]-Methylstyrene-vinyltoluene
 copolymer resins (molar ratio 1[alpha]-
 methylstyrene to 3 vinyltoluene).
Modified kaolin clay (CAS Reg. No. 1344- For use only as a component of
 00-9) is produced by the reaction of     coatings in paper and
 sodium silicate (CAS Reg. No. 1344-09-   paperboard products at a level
 8) and kaolinite clay (CAS Reg. No.      not to exceed 9 percent by
 1332-58-7) under hydrothermal            weight of the coating intended
 conditions. The reaction product has a   for use in contact with food
 molecular weight between 246 and 365     of Types I through IX
 and consists of 46 to 55 percent         described in table 1 of
 silicon dioxide (Si02), 28 to 42         paragraph (c) of this section
 percent aluminum oxide (A1203), and 2    under conditions of use C
 to 7 percent of sodium oxide (Na20).     through H described in table 2
 The reaction product will not consist    of paragraph (c) of this
 of more than 70 percent modified         section.
 kaolin clay.
Naphthalene sulfonic acid-formaldehyde
 condensate, sodium salt.
Oleyl alcohol..........................
Oxazolidinylethylmethacrylate (CAS       For use only as a binder for
 Registry No. 46236-15-1) copolymer       pigment coatings as a binder
 with ethyl acrylate and methyl           level not to exceed 4.0
 methacrylate, and containing not more    percent by weight of dry paper
 than 6 percent by weight of              or paperboard.
 oxazolidinylethylmethacrylate. Maximum
 nitrogen content shall be 0.5 percent
 and number average molecular weight of
 that portion of the copolymer soluble
 in tetrahydrofuran shall be not less
 than 50,000.
Pentaerythritol tetrastearate..........

[[Page 214]]


Petroleum alicyclic hydrocarbon resins,  For use only as modifiers in
 or the hydrogenated product thereof,     waxpolymer blend coatings for
 meeting the following specifications:    corrugated paperboard intended
 Softening point 97 [deg]C minimum, as    for use in bulk packaging or
 determined by ASTM method E28-67         raw fruits, raw vegetables,
 (Reapproved 1982), ``Standard Test       iced meat, iced fish, and iced
 Method for Softening Point by Ring and   poultry; and limited to use at
 Ball Apparatus;'' aniline point 120      a level not to exceed 30
 [deg]C minimum, as determined by ASTM    weight-percent of the coating
 method D611-82, ``Standard Test          solids.
 Methods for Aniline Point and Mixed
 Aniline Point of Petroleum Products
 and Hydrocarbon Solvents,'' which are
 incorporated by reference (Copies may
 be obtained from the American Society
 for Testing Materials, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/federal--
 register/code--of--federal--
 regulations/ibr--locations.html.).
 Specific gravity 0.96-0.99 (20 [deg]C/
 20 [deg]C). Such petroleum hydrocarbon
 resins are produced by the catalytic
 polymerization of dienes and olefins
 from low-boiling distillates of
 cracked petroleum stocks that contain
 no material boiling over 200 [deg]C
 and that meet the ultraviolet
 absorbance limits prescribed in Sec.
 172.880(b) of this chapter when
 subjected to the analytical procedure
 described in Sec.   172.886(b) of this
 chapter, modified as follows: Treat
 the product as in the first paragraph
 under ``Procedure'' in Sec.
 172.250(b)(3) of this chapter. Then
 proceed with Sec.   172.886(b) of this
 chapter, starting with the paragraph
 commencing with ``Promptly complete
 transfer of the sample * * *''.
Polyester resin formed by the reaction
 of the methyl ester of rosin, phthalic
 anhydride, maleic anhydride and
 ethylene glycol, such that the
 polyester resin has an acid number of
 4 to 11, a drop-softening point of 70
 [deg]C-92 [deg]C., and a color of K or
 paler.
Polyester resin produced by reacting
 the acid groups in montan wax with
 ethylene glycol.
Polyethylene, oxidized.................  Complying with Sec.   177.1620
                                          of this chapter.
Polyethylene reacted with maleic
 anhydride such that the modified
 polyethylene has a saponification
 number not in excess of 6 after
 Soxhlet extraction for 24 hours with
 anhydrous ethyl alcohol.
Polyoxyethylated (40 moles) tallow       Not to exceed 300 p.p.m. in
 alcohol sulfate, sodium salt.            finished coated paper or
                                          paperboard.
Polyoxypropylene-polyoxyethylene block
 polymers (minimum molecular weight
 6,800).
Polyvinyl acetate......................
Polyvinyl alcohol (minimum viscosity of
 4% aqueous solution at 20 [deg]C. of 4
 centipoises).
Polyvinyl butyral......................
Polyvinyl formal.......................
Polyvinylidene chloride................
Polyvinyl pyrrolidone..................
Polyvinyl stearate.....................
Propylene glycol mono- and diesters of
 fats and fatty acids.
Siloxanes and silicones; platinum-       For use only as a surface
 catalyzed reaction product of vinyl-     coating. Platinum content not
 containing dimethyl polysiloxane (CAS    to exceed 200 parts per
 Reg. Nos. 68083-19-2 and 68083-18-1)     million.
 with methyl hydrogen polysiloxane (CAS  1. In coatings for paper and
 Reg. No. 63148-57-2) or dimethyl         paperboard provided the
 (methyl hydrogen) polysiloxane (CAS      coating contacts food only of
 Reg. No. 68037-59-2). Diallyl maleate    the types identified in
 (CAS Reg No. 999-21-3), dimethyl         paragraph (c) of this section,
 maleate (CAS Reg. No. 624-48-6), 1-      table 1, under Types I, II,
 ethynyl-1-cyclohexanol (CAS Reg. No.     VI, and VII-B when used under
 78-27-3) and vinyl acetate (CAS Reg.     conditions of use E, F, and G
 No. 108-05-4) may be used as optional    described in table 2 of
 polymerization inhibitors.               paragraph (c) of this section.
                                         2. In coatings for paper and
                                          paperboard provided the
                                          coating contacts food only of
                                          the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types III, IV,
                                          V, VII-A, VIII, and IX when
                                          used under conditions of use A
                                          through H described in table 2
                                          of paragraph (c) of this
                                          section.

[[Page 215]]


Siloxanes and silicones; platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a release coating for
 Reg. Nos. 68083-19-2 and 68083-18-1),    pressure sensitive adhesives.
 with methyl hydrogen polysiloxane (CAS
 Reg. No. 63148-57-2). Dimethyl maleate
 (CAS Reg. No. 624-48-6), vinyl acetate
 (CAS Reg. No. 108-05-4), dibutyl
 maleate (CAS Reg. No. 105-76-0) and
 diallyl maleate (CAS Reg. No. 999-21-
 3) may be used as optional
 polymerization inhibitors. The polymer
 may also contain C16-C18 olefins (CAS
 Reg. No. 68855-60-7) as a control
 release agent.
Sodium decylbenzenesulfonate...........
Sodium dihexyl sulfosuccinate..........
Sodium n-dodecylpolyethoxy (50 moles)    For use only as an emulsifier
 sulfate-sodium                           in coatings that contact food
 isododecylphenoxypolyethoxy (40 moles)   only of the types identified
 sulfate mixtures.                        in paragraph (c) of this
                                          section, table 1, under Types
                                          IV-A, V, VII, VIII, and IX;
                                          and limited to use at levels
                                          not to exceed 0.75 percent by
                                          weight of the coating solids.
Sodium 2-ethylhexyl sulfate............
Sodium oleoyl isopropanolamide
 sulfosuccinate.
Sodium pentachlorophenate..............  For use only as preservative
                                          for coating formulations.
Sodium o-phenylphenate.................   Do.
Sodium vinyl sulfonate polymerized.....
Sodium xylenesulfonate (CAS Reg. No.     For use only in paper and
 1300-72-7).                              paperboard coatings at levels
                                          not to exceed 0.01 percent by
                                          weight of the finished paper
                                          and paperboard.
Styrene copolymers produced by           For use only as a coating or
 copolymerizing styrene with maleic       component of coatings and
 anhydride and its methyl and butyl       limited to use at a level not
 (sec- or iso-) esters. Such copolymers   to exceed 1% by weight of
 may contain [beta]-nitrostyrene as a     paper or paperboard substrate.
 polymerization chain terminator.
Styrene polymers made by the             For use only in contact with
 polymerization of any combination of     foods of Types IV-A, V, and
 styrene or alpha methyl styrene with     VII in table 1 of paragraph
 acrylic acid, methacrylic acid, 2-       (c) of this section, under use
 ethyl hexyl acrylate, methyl             conditions E through G in
 methacrylate, and butyl acrylate. The    table 2 of paragraph (c), and
 styrene and alpha methyl styrene,        with foods of Types VIII and
 individually, may constitute from 0 to   IX without use temperature
 80 weight percent of the polymer. The    restriction.
 other monomers, individually, may be
 from 0 to 40 weight percent of the
 polymer. The polymer number average
 molecular weight (Mn) shall be at
 least 2,000 (as determined by gel
 permeation chromatography). The acid
 number of the polymer shall be less
 than 250. The monomer content shall be
 less than 0.5 percent.
Styrene-acrylic copolymers (CAS Reg.     For use only as a component of
 No. 25950-40-7 produced by               coatings and limited to use at
 polymerizing 77 to 83 parts by weight    a level not to exceed 20
 of styrene with 13 to 17 parts of        percent by weight of the
 methyl methacrylate, 3 to 4 parts of     coating solids.
 butyl methacrylate, 0.5 to 2.5 parts
 of methacrylic acid, and 0.1 to 0.3
 part of butyl acrylate such that the
 finished copolymers have a minimum
 number average molecular weight
 greater than 100,000 and a level of
 residual styrene monomer in the
 polymer not to exceed 0.1 percent by
 weight.
Styrene-butadiene copolymers produced
 by copolymerizing styrene-butadiene
 with one or more of the monomer:
 acrylamide, acrylic acid, fumaric
 acid, 2-hydroxyethyl acrylate,
 itaconic acid, and methacrylic acid.
 The finished copolymers shall contain
 not more than 10 weight percent of
 total polymer units derived from
 acrylic acid, fumaric acid, 2-
 hydroxyethyl acrylate, itaconic acid
 and methacrylic acid, and shall
 contain not more than 2 weight percent
 of polymer units derived from
 acrylamide.
Styrene-butadiene copolymers with 2-
 hydroxyethyl acrylate and acrylic acid
 containing not more than 15 weight
 percent acrylic acid and no more than
 20 weight percent of a combination of
 2-hydroxyethyl acrylate and acrylic
 acid.
Styrene-butadiene-vinylidene chloride    For use only as coatings or
 copolymers containing not more than 40   components of coatings.
 weight percent of vinylidene chloride
 in the finished copol ymers. The
 finished copolymers may contain not
 more than 10 weight percent of total
 polymer units derived from acrylic
 acid, fumaric acid, 2-hydroxyethyl
 acrylate, itaconic acid, and/or
 methacrylic acid.

[[Page 216]]


Styrene-dimethylstyrene-[alpha]-         For use only in coatings for
 methylstyrene copolymers produced by     paper and paperboard intended
 polymerizing equimolar ratios of the     for use in contact with
 three comonomers such that the           nonfatty food and limited to
 finished copol ymers have a minimum      use at a level not to exceed
 average molecular weight of 835 as       50% by weight of the coating
 determined by ASTM method D2503-82,      solids.
 ``Standard Test Method for Molecular
 Weight (Relative Molecular Mass) of
 Hydrocarbons by Thermoelectric
 Measurement of Vapor Pressure,'' which
 is incorporated by reference. Copies
 may be obtained from the American
 Society for Testing Materials, 100
 Barr Harbor Dr., West Conshohocken,
 Philadelphia, PA 19428-2959, or may be
 examined at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal--register/
 code--of--federal--regulations/ibr--
 locations.html..
Styrene-isobutylene copolymers (weight   For use only in coatings for
 average molecular weight not less than   paper and paperboard intended
 6,300).                                  for use in contact under
                                          conditions of use D G
                                          described in table 2 of
                                          paragraph (c) of this section,
                                          with food of Types I, II, IV-
                                          B, VI-B, VII-B, and VIII
                                          described in table 1 of
                                          paragraph (c) of this section;
                                          and limited to use at a level
                                          not to exceed 40 percent by
                                          weight of the coating solids.
Styrene-maleic anhydride copolymers....  For use only as a coating or
                                          component of coatings and
                                          limited for use at a level not
                                          to exceed 2 percent by weight
                                          of paper or paperboard
                                          substrate.
Styrene-methacrylic acid copolymers
 containing no more than 5 weight
 percent of polymer units derived from
 methacrylic acid.
Styrene-vinylidene chloride copol ymers  For use only as coatings or
 containing not more than 40 weight       components of coatings.
 percent of vinylidene chloride in the
 finished copol ymers. The finished
 copolymers may contain not more than 5
 weight percent of total polymer units
 derived from acrylic acid, fumaric
 acid, itaconic acid, and/or
 methacrylic acid.
2-Sulfoethyl methacrylate, sodium salt   For use only in copolymer
 [Chemical Abstracts Service No. 1804-    coatings under conditions of
 87-1].                                   use E, F, and G described in
                                          paragraph (c) of this section,
                                          table 2, and limited to use at
                                          a level not to exceed 2.0
                                          percent by weight of the dry
                                          copolymer coating.
[alpha][p-(1,1,3,3-Tetramethylbutyl)     For use only as a surface-
 phenyl]-omega-hydroxypoly                active agent at levels not to
 (oxyethylene) hydrogen sulfate, sodium   exceed 3 percent by weight of
 salt mixture with [alpha]-[p-(1,1,3,3-   vinyl acetate polymer with
 tetramethylbutyl)-phenyl]-omega-         ethylene and N-(hydroxymethyl)
 hydroxypoly (oxyethylene) with both      acrylamide intended for use in
 substances having a poly(oxyethylene)    coatings for paper and
 content averaging 3 moles.               paperboard intended for use in
                                          contact with foods:
                                         1. Of the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types I, II,
                                          III, IV, VI-B, and VII, and
                                          under the conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
                                         2. Of the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types V, VIII
                                          and IX and under the
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use C,
                                          D, E, F, and G.
Tetrasodium N-(1,2-dicarboxyethyl)-N-    For use only as an emulsifier
 octadecylsulfo-succinamate.              in resin latex coatings, and
                                          limited to use at a level not
                                          to exceed 0.05% by weight of
                                          the coating solids.
Toluenesulfonamide-formaldehyde resins.

[[Page 217]]


Vinyl acetate copolymers produced by
 copolymerizing vinyl acetate with one
 or more of the monomers acrylamide,
 acrylic acid, acrylonitrile, bicyclo-
 [2.2.1]hept-2-ene-6-methylacrylate,
 butyl acrylate, crotonic acid, decyl
 acrylate, diallyl fumarate, diallyl
 maleate, diallyl phthalate, dibutyl
 fumarate, dibutyl itaconate,
 dibutylmaleate, di(2-ethylhexyl)
 maleate, divinyl benzene, ethyl
 acrylate, 2-ethyl-hexyl acrylate,
 fumaric acid, itaconic acid, maleic
 acid, methacrylic acid, methyl
 acrylate, methyl methacrylate, mono(2-
 ethylhexyl) maleate, monoethyl
 maleate, styrene, vinyl butyrate,
 vinyl crotonate, vinyl hexoate,
 vinylidene chloride, vinyl
 pelargonate, vinyl propionate, vinyl
 pyrrolidone, vinyl stearate, and vinyl
 sulfonic acid. The finished copolymers
 shall contain at least 50 weight
 percent of polymer units derived from
 vinyl acetate and shall contain no
 more than 5 weight percent of total
 polymer units derived from acrylamide,
 acrylic acid, crotonic acid, decyl
 acrylate, dibutyl itaconate, di(2-
 ethylhexyl) maleate, fumaric acid,
 itaconic acid, maleic acid,
 methacrylic acid, mono(2-ethylhexyl)
 maleate, monoethyl maleate, vinyl
 butyrate, vinyl hexoate, vinyl
 pelargonate, vinyl propionate, vinyl
 stearate, and vinyl sulfonic acid.
Vinyl acetate polymer with ethylene and  For use only in coatings for
 N-(hydroxymethyl) acrylamide             paper and paperboard intended
 containing not more than 6 weight        for use in contact with foods:
 percent of total polymer units derived  1. Of the types identified in
 from N-(hydroxymethyl) acrylamide.       paragraph (c) of this section,
                                          table 1, under Types I, II,
                                          III, IV, VI B, and VII and
                                          under the conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
                                         2. Of the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types V, VIII,
                                          and IX and under the
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use C,
                                          D, E, F, and G.
Vinyl chloride copolymers produced by
 copolymerizing vinyl chloride with one
 or more of the monomers acrylonitrile;
 fumaric acid and its methyl, ethyl,
 propyl, butyl, amyl, hexyl, heptyl, or
 octyl esters; maleic acid and its
 methyl, ethyl, propyl, butyl, amyl,
 hexyl, heptyl, or octyl esters; maleic
 anhydride; 5-norbornene-2, 3-
 dicarboxylic acid, mono-n-butyl ester;
 vinyl acetate-and vinylidene chloride.
 The finished copolymers shall contain
 at least 50 weight percent of polymer
 units derived from vinyl chloride:
 shall contain no more than 5 weight
 percent of total polymer units derived
 from fumaric and/or maleic acid and/or
 their methyl, ethyl, propyl, butyl,
 amyl, heptyl, or octyl monoesters or
 from maleic anhydride or from mono-n-
 butyl ester of 5-norbornene-2, 3-
 dicarboxylic acid (however, in any
 case the finished copolymers shall
 contain no more than 4 weight percent
 of total polymer units derived from
 mono-n-butyl ester of 5-norbornene-2,3-
 dicarboxylic acid).
Vinyl chloride-vinyl acetate hydroxyl-
 modified copolymers.
Vinyl chloride-vinyl acetate hydroxyl-
 modified copolymers reacted with
 trimellitic anhydride.
Vinylidene chloride copolymers produced
 by copolymerizing vinylidene chloride
 with one or more of the monomers
 acrylamide acrylic acid,
 acrylonitrile, butyl acrylate, butyl
 methacrylate ethyl acrylate, ethyl
 methacrylate, fumaric acid, itaconic
 acid, methacrylic acid, methyl
 acrylate, methyl methacrylate,
 octadecyl methacrylate, propyl
 acrylate, propyl methacrylate, vinyl
 chloride and vinyl sulfonic acid. The
 finished copolymers shall contain at
 least 50 weight percent of polymer
 units derived from vinylidene
 chloride; and shall contain no more
 than 5 weight percent of total polymer
 units derived from acrylamide, acrylic
 acid, fumaric acid, itaconic acid,
 methacrylic acid, octadecyl
 methacrylate, and vinyl sulfonic acid.
Colorants:.............................
  Aluminum.............................  For use as a colorant only.
  Aluminum hydrate.....................   Do.
  Aluminum and potassium silicate         Do.
   (mica).
  Aluminum mono-, di-, and tri stearate   Do.
  Aluminum silicate (China clay).......   Do.
  Barium sulfate.......................   Do.
  Bentonite............................   Do.
  Bentonite, modified with                Do.
   dimethyldioctadecylammonium ion.
  Burnt umber..........................   Do.

[[Page 218]]


  Calcium carbonate....................   Do.
  Calcium silicate.....................   Do.
  Calcium sulfate......................   Do.
  Carbon black (channel process).......   Do.
  Cobalt aluminate.....................   Do.
  Diatomaceous earth...................   Do.
  Iron oxides..........................   Do.
  Magnesium oxide......................   Do.
  Magnesium silicate (talc)............   Do.
  Phthalocyanine blue (C.I. pigment       Do.
   blue 15, 15:1, 15:2, 15:3, and 15:4;
   C.I. No. 74160; CAS Reg. No. 147-14-
   8).
  Raw sienna...........................   Do.
  Silica...............................   Do.
  Tartrazine lake (certified FD&C         Do.
   Yellow No. 5 only).
  Titanium dioxide.....................   Do.
  Titanium dioxide-barium sulfate......   Do.
  Titanium dioxide-magnesium...........   Do.
   silicate............................
  Zinc carbonate.......................   Do.
  Zinc oxide...........................   Do.
------------------------------------------------------------------------

    (c) The food-contact surface of the paper and paperboard in the 
finished form in which it is to contact food, when extracted with the 
solvent or solvents characterizing the type of food, and under 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from tables 1 and 2 of this paragraph, shall 
yield net chloroform-soluble extractives (corrected for wax, petrolatum, 
mineral oil and zinc extractives as zinc oleate) not to exceed 0.5 
milligram per square inch of food-contact surface as determined by the 
methods described in paragraph (d) of this section.

                Table 1--Types of Raw and Processed Foods
I. Nonacid, aqueous products; may contain salt or sugar or both (pH
 above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and
 including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
 contain salt, and including water-in-oil emulsions of low- or high-fat
 content.
IV. Dairy products and modifications:
  A. Water-in-oil emulsions, high- or low-fat.
  B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
  A. Containing up to 8 percent of alcohol.
  B. Nonalcoholic.
  C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX of
 this table:
  A. Moist bakery products with surface containing free fat or oil.
  B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end
 test required).
IX. Dry solids with the surface containing free fat or oil.



 Table 2--Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food-
    Contact Surface of Uncoated or Coated Paper and Paperboard, Using Solvents Simulating Types of Foods and
                                                    Beverages
----------------------------------------------------------------------------------------------------------------
                                                                    Food-simulating solvents
                                              ------------------------------------------------------------------
                                                    Water         Heptane \1\       8 percent       50 percent
      Condition of use         Types of food  ----------------------------------     alcohol          alcohol
                               (see table 1)                                    --------------------------------
                                                   Time and         Time and         Time and        Time and
                                                 temperature      temperature      temperature      temperature
----------------------------------------------------------------------------------------------------------------
A. High temperature heat-     I, IV-B, VII-B.  250 [deg]F, 2    ...............  ...............  ..............
 sterilized (e.g., over 212                     hr.
 [deg]F).
                              III, IV-A, VII-  ......do.......  150 [deg]F, 2    ...............  ..............
                               A.                                hr.
B. Boiling water sterilized.  II, VII-B......  212 [deg]F, 30
                                                min.
                              III, VII-A.....  ......do.......  120 [deg]F, 30   ...............  ..............
                                                                 min.
C. Hot filled or pasteurized  II, IV-B, VII-B  Fill boiling,    ...............  ...............  ..............
 above 150 [deg]F.                              cool to 100
                                                [deg]F.

[[Page 219]]


                              III, IV-A, VII-  ......do.......  120 [deg]F, 15   ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
D. Hot filled or pasteurized  II, IV-B, VI-B,  ...............  ...............  ...............  ..............
 below 150 [deg]F.
                              VII-B..........  150 [deg]F, 2    ...............  ...............  ..............
                                                hr.
                              III, IV-A, VII-  ......do.......  100 [deg]F, 30   ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  150 [deg]F, 2    ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............   150 [deg]F, 2
                                                                                                             hr.
E. Room temperature filled    I, II, IV-B, VI- 120 [deg]F, 24   ...............  ...............  ..............
 and stored (no thermal        B, VII-B.        hr.
 treatment in the container).
                              III, IV-A, VII-  ......do.......  70 [deg]F, 30    ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  120 [deg]F, 24   ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............  120 [deg]F, 24
                                                                                                             hr.
F. Refrigerated storage (no   III, IV-A, VII-  70 [deg]F, 48    70 [deg]F, 30    ...............  ..............
 thermal treatment in the      A.               hr.              min.
 container).
                              I, II, IV-B, VI- ......do.......  ...............  ...............  ..............
                               B, VII-B.
                              VI-A...........  ...............  ...............  70 [deg]F, 48    ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............   70 [deg]F, 48
                                                                                                             hr.
G. Frozen storage (no         I, II, IV-B,     70 [deg]F, 24    ...............  ...............  ..............
 thermal treatment in the      VII-B.           hr.
 container).
                              III, VII-A.....  ......do.......  70 [deg]F, 30    ...............  ..............
                                                                 min.
H. Frozen or refrigerated
 storage: Ready-prepared
 foods intended to be
 reheated in container at
 time of use:
  1. Aqueous or oil-in-water  I, II, IV-B,     212 [deg]F, 30   ...............  ...............  ..............
   emulsion of high- or low-   VII-B.           min.
   fat.
  2. Aqueous, high- or low-   III, IV-A, VII-  ......do.......  120 [deg]F, 30   ...............  ..............
   free oil or fat.            A, IX.                            min.
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractability results must be divided by a factor of five in arriving at the extractability for a
  food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required
  in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk
  packaging of iced meat, iced fish, and iced poultry.

    (d) Analytical methods--(1) Selection of extractability conditions. 
First ascertain the type of food product (table 1, paragraph (c) of this 
section) that is being packed commercially in the paper or paperboard 
and the normal conditions of thermal treatment used in packaging the 
type of food involved. Using table 2, paragraph (c) of this section, 
select the food-simulating solvent or solvents and the time-temperature 
exaggerations of the paper or paperboard use conditions. Having selected 
the appropriate food-simulating solvent or solvents and the time-
temperature exaggeration over normal use, follow the applicable 
extraction procedure.
    (2) Reagents--(i) Water. All water used in extraction procedures 
should be freshly demineralized (deionized) distilled water.
    (ii) n-Heptane. Reagent grade, freshly redistilled before use, using 
only material boiling at 208 [deg]F.
    (iii) Alcohol. 8 or 50 percent (by volume), prepared from 
undenatured 95 percent ethyl alcohol diluted with demineralized 
(deionized) distilled water.
    (iv) Chloroform. Reagent grade, freshly redistilled before use, or a 
grade having an established consistently low blank.
    (3) Selection of test method. Paper or paperboard ready for use in 
packaging shall be tested by use of the extraction cell described in 
``Official Methods of Analysis of the Association of Official

[[Page 220]]

Analytical Chemists,'' 13th Ed. (1980), sections 21.010-21.015, under 
``Exposing Flexible Barrier Materials for Extraction,'' which is 
incorporated by reference (Copies may be obtained from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.); 
also described in ASTM method F34-76 (Reapproved 1980), ``Standard Test 
Method for Liquid Extraction of Flexible Barrier Materials,'' which is 
incorporated by reference (copies may be obtained from the American 
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.), except that formed paper and paperboard products may 
be tested in the container by adapting the in-container methods 
described in Sec.  175.300(e) of this chapter. Formed paper and 
paperboard products such as containers and lids, that cannot be tested 
satisfactorily by any of the above methods may be tested in specially 
designed extraction equipment, usually consisting of clamping devices 
that fit the closure or container so that the food-contact surface can 
be tested, or, if flat samples can be cut from the formed paper or 
paperboard products without destroying the integrity of the food-contact 
surface, they may be tested by adapting the following ``sandwich'' 
method:
    (i) Apparatus. (a) Thermostated (1.0 [deg]F) 
water bath, variable between 70 [deg]F and 120 [deg]F water bath cover 
capable of holding at least one 800-milliliter beaker partially 
submersed in bath.
    (b) Analytical balance sensitive to 0.1 milligram with an 
approximate capacity of 100 grams.
    (c) Tongs.
    (d) Hood and hot-plate facilities.
    (e) Forced draft oven.


For each extraction, the following additional apparatus is necessary:
    (f) One No. 2 paper clip.
    (g) One 800-milliliter beaker with watch-glass cover.
    (h) One 250-milliliter beaker.
    (i) Five 2\1/2\-inch-square aluminum screens (standard aluminum 
window screening is acceptable).
    (j) One wire capable of supporting sample stack.
    (ii) Procedure. (a) For each extraction, accurately cut eight 2\1/
2\-inch-square samples from the formed paper or paperboard product to be 
tested.
    (b) Carefully stack the eight 2\1/2\-inch-square samples and the 
five 2\1/2\-inch-square aluminum screens in sandwich form such that the 
food-contact side of each sample is always next to an aluminum screen, 
as follows: Screen, sample, sample, screen, sample, sample, screen, etc. 
Clip the sandwich together carefully with a No. 2 paper clip, leaving 
just enough space at the top to slip a wire through.
    (c) Place an 800-milliliter beaker containing 100-milliliters of the 
appropriate food-simulating solvent into the constant temperature bath, 
cover with a watch glass and condition at the desired temperature.
    (d) After conditioning, carefully lower the sample sandwich with 
tongs into the beaker.
    (e) At the end of the extraction period, using the tongs, carefully 
lift out the sample sandwich and hang it over the beaker with the wire.
    (f) After draining, pour the food-simulating solvent solution into a 
tared 250-milliliter beaker. Rinse the 800-milliliter beaker three 
times, using a total of not more than 50 milliliters of the required 
solvent.
    (g) Determine total nonvolatile extractives in accordance with 
paragraph (d)(5) of this section.
    (4) Selection of samples. Quadruplicate samples should be tested, 
using for each replicate sample the number of cups, containers, or 
preformed or converted products nearest to an area of 100 square inches.
    (5) Determination of amount of extractives--(i) Total residues. At 
the end of the exposure period, remove the test container or test cell 
from the oven

[[Page 221]]

and combine the solvent for each replicate in a clean Pyrex (or 
equivalent) flask or beaker being sure to rinse the test container or 
cell with a small quantity of clean solvent. Evaporate the food-
simulating solvents to about 100 milliliters in the flask or beaker, and 
transfer to a clean, tared evaporating dish (platinum or Pyrex), washing 
the flask three times with small portions of solvent used in the 
extraction procedure, and evaporate to a few milliliters on a 
nonsparking, low-temperature hotplate. The last few milliliters should 
be evaporated in an oven maintained at a temperature of approximately 
221 [deg]F. Cool the evaporating dish in a desiccator for 30 minutes and 
weigh the residue to the nearest 0.1 milligram, (e). Calculate the 
extractives in milligrams per square inch of the container or sheeted 
paper or paperboard surface.
    (a) Water and 8- and 50-percent alcohol. Milligrams extractives per 
square inch=(e)/(s).
    (b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)

where:

e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane under 
exaggerated time-temperature test conditions compared to the amount 
extracted by a fat or oil under exaggerated conditions of thermal 
sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Corrected chloroform-soluble extractives residue.
e' or ee' is substituted for e in the above equations when necessary.


If when calculated by the equations in paragraph (d)(5)(i) (a) and (b) 
of this section, the extractives in milligrams per square inch exceeds 
the limitations prescribed in paragraph (c) of this section, proceed to 
paragraph (d)(5)(ii) of this section (method for determining the amount 
of chloroform-soluble extractives residues).
    (ii) Chloroform-soluble extractives residue. Add 50 milliliters of 
chloroform (freshly distilled reagent grade or a grade having an 
established consistently low blank) to the dried and weighed residue, 
(e), in the evaporating dish obtained in paragraph (d)(5)(i) of this 
section. Warm carefully, and filter through Whatman No. 41 filter paper 
(or equivalent) in a Pyrex (or equivalent) funnel, collecting the 
filtrate in a clean, tared evaporating dish (platinum or Pyrex). Repeat 
the chloroform extraction, washing the filter paper with this second 
portion of chloroform. Add this filtrate to the original filtrate and 
evaporate the total down to a few milliliters on a low-temperature 
hotplate. The last few milliliters should be evaporated in an oven 
maintained at approximately 221 [deg]F. Cool the evaporating dish in a 
desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get 
the chloroform-soluble extractives residue ('). This ' is substituted 
for e in the equations in paragraph (d)(5)(i) (a) and (b) of this 
section. If the chloroform-soluble extractives in milligrams per square 
inch still exceeds the limitation prescribed in paragraph (c) of this 
section, proceed to paragraph (d)(5)(iii) of this section (method for 
determining corrected chloroform-soluble extractives residue).
    (iii) Corrected chloroform-soluble extractives residue--(a) 
Correction for zinc extractives. Ash the residue in the evaporating dish 
by heating gently over a Meker-type burner to destroy organic matter and 
hold at red heat for about 1 minute. Cool in the air for 3 minutes, and 
place the evaporating dish in the desiccator for 30 minutes and weigh to 
the nearest 0.1 milligram. Analyze this ash for zinc by standard 
Association of Official Agricultural Chemists methods or equivalent. 
Calculate the zinc in the ash as zinc oleate, and subtract from the 
weight of chloroform-soluble extractives residue (') to obtain the zinc-
corrected chloroform-soluble extractives residue (e'). This e' is 
substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of 
this section.
    (b) Correction for wax, petrolatum, and mineral oil--(1) Apparatus. 
Standard 10 millimeter inside diameter x 60 centimeter chromatographic 
column (or standard 50-milliliter buret with an inside diameter of 10-11 
millimeters) with a stopcock of glass, perfluorocarbon resin, or 
equivalent material. The column (or buret) may be optionally equipped 
with an integral coarse, fritted glass disc and the top of

[[Page 222]]

the column (or buret) may be optionally fitted with a 100-millimeter 
solvent reservoir.
    (2) Preparation of column. Place a snug pledget of fine glass wool 
in the bottom of the column (or buret) if the column (or buret) is not 
equipped with integral coarse, fritted glass disc. Overlay the glass 
wool pledget (or fritted glass disc) with a 15-20 millimeter deep layer 
of fine sand. Measure in a graduated cylinder 15 milliliters of 
chromatographic grade aluminum oxide (80-200 mesh) that has been tightly 
settled by tapping the cylinder. Transfer the aluminum oxide to the 
chromatographic tube, tapping the tube during and after the transfer so 
as to tightly settle the aluminum oxide. Overlay the layer of aluminum 
oxide with a 1.0-1.5 centimeter deep layer of anhydrous sodium sulfate 
and on top of this place an 8-10 millimeter thick plug of fine glass 
wool. Next carefully add about 25 milliliters of heptane to the column 
with stopcock open, and allow the heptane to pass through the column 
until the top level of the liquid just passes into the top glass wool 
plug in the column, and close stopcock.
    (3) Chromatographing of sample extract--(i) For chloroform residues 
weighing 0.5 gram or less. To the dried and weighed chloroform-soluble 
extract residue in the evaporating dish, obtained in paragraph 
(d)(5)(ii) of this section, add 20 milliliters of heptane and stir. If 
necessary, heat carefully to dissolve the residue. Additional heptane 
not to exceed a total volume of 50 milliliters may be used if necessary 
to complete dissolving. Cool to room temperature. (If solution becomes 
cloudy, use the procedure in paragraph (d)(5)(iii)(b)(3)(ii) of this 
section to obtain an aliquot of heptane solution calculated to contain 
0.1-0.5 gram of chloroform-soluble extract residue.) Transfer the clear 
liquid solution to the column (or buret). Rinse the dish with 10 
millimeters of additional heptane and add to column. Allow the liquid to 
pass through the column into a clean, tared evaporating dish (platinum 
or Pyrex) at a dropwise rate of about 2 milliliters per minute until the 
liquid surface reaches the top glass wool plug; then close the stopcock 
temporarily. Rinse the Pyrex flask which contained the filtrate with an 
additional 10-15 milliliters of heptane and add to the column. Wash 
(elute) the column with more heptane collecting about 100 milliliters of 
total eluate including that already collected in the evaporating dish. 
Evaporate the combined eluate in the evaporating dish to dryness on a 
steam bath. Dry the residue for 15 minutes in an oven maintained at a 
temperature of approximately 221 [deg]F. Cool the evaporating dish in a 
desiccator for 30 minutes and weigh the residue to the nearest 0.1 
milligram. Subtract the weight of the residue from the weight of 
chloroform-soluble extractives residue (') to obtain the wax-, 
petrolatum-, and mineral oil-corrected chloroform-soluble extractives 
residue (e'). This e' is substituted for e in the equations in paragraph 
(d)(5)(i) (a) and (b) of this section.
    (ii) For chloroform residues weighing more than 0.5 gram. Redissolve 
the dried and weighed chloroform-soluble extract residue as described in 
paragraph (d)(5)(iii)(b)(3)(i) of this section using proportionately 
larger quantities of heptane. Transfer the heptane solution to an 
appropriate-sized volumetric flask (i.e., a 250-milliliter flask for 
about 2.5 grams of residue) and adjust to volume with additional 
heptane. Pipette out an aliquot (about 50 milliliters) calculated to 
contain 0.1-0.5 gram of the chloroform-soluble extract residue and 
analyze chromatographically as described in paragraph 
(d)(5)(iii)(b)(3)(i) of this section. In this case the weight of the 
dried residue from the heptane eluate must be multiplied by the dilution 
factor to obtain the weight of wax, petrolatum, and mineral oil residue 
to be subtracted from the weight of chloroform-soluble extractives 
residue (') to obtain the wax-, petrolatum-, and mineral oil-corrected 
chloroform-soluble extractives residue (e'). This e' is substituted for 
e in the equations in paragraph (d)(5)(i) (a) and (b) of this section. 
(Note: In the case of chloroform-soluble extracts which contain high 
melting waxes (melting point greater than 170 [deg]F), it may be 
necessary to dilute the heptane solution further so that a 50-milliliter 
aliquot will contain only 0.1-0.2 gram of the chloroform-soluble extract 
residue.)

[[Page 223]]

    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec.  180.22 of this chapter, except where the 
copolymers are restricted to use in contact with food only of the type 
identified in paragraph (c), table 1 under Category VIII.

[42 FR 14554, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting Sec.  
176.170, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 176, Section 170


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